Doxycycline as post-exposure prophylaxis (doxy-PEP) has emerged as an efficacious strategy to reduce Chlamydia trachomatis (C. trachomatis), Neisseria gonorrhoeae (N. gonorrhoeae) and syphilis (sexually transmitted infections (STIs)) among gay, bisexual and other men who have sex with men (GBM). There is a need to identify prescribing criteria that maximise the number of STIs averted while minimising excessive use.

In this prospective longitudinal cohort study with repeated measures and biobehavioural data collection, participants completed a questionnaire and tested for STIs at each visit.

Community-based, population-level study conducted in three large Canadian cities between February 2017 and July 2023.

2449 GBM were recruited through respondent-driven sampling (RDS); 1998 had ≥1 follow-up visit, contributing 7551 person-years of observation. Eligible participants were aged ≥16 years, cis- or transgender men, reported sex with another man in the past 6 months and resided in Montreal, Toronto or Vancouver.

Adjusted rate ratios (aRR) of STIs, accounting for RDS recruitment, loss to follow-up and confounding were estimated using generalised estimating equations (GEE) Poisson regression. For identified STI risk factors, the proportions of STIs averted through doxy-PEP prescription (based on the efficacy of doxy-PEP for each bacterial STI) and the number needed to treat (NNT) for 1 year to avert one STI, assuming 100% adherence, were calculated.

Among 1998 participants, the combined incidence rate of any C. trachomatis, N. gonorrhoeae and syphilis infection was 29.5 (95%CI 27.3 to 31.9) per 100 person-years. STI risk factors that had the most impact as doxy-PEP criteria were history of any of the three STIs in the past 12 months (P12M) (aRR=2.0, 95% CI 1.8 to 2.2, 36% STI averted, NNT=2.1); ≥10 male sexual partners in the past 6 months (P6M) (aRR=3.8, 95% CI 3.0 to 4.9, 41% STI averted, NNT=2.4); HIV-pre-exposure prophylaxis (PrEP) use P6M (aRR=1.7, 95% CI 1.5 to 2.0, 29% STI averted, NNT=2.5); use of any chemsex-related substance P6M (aRR=1.2, 95% CI 1.1 to 1.4, 28% STI averted, NNT=2.6); and group sex event attendance P6M (aRR=1.2, 95% CI 1.1 to 1.3, 27% STI averted, NNT=2.3). Reporting≥10 male sex partners P6M represented the most useful criterion for syphilis prevention (52% syphilis infections averted, NNT=20). Prescribing doxy-PEP to GBM having any of the following STI risk factors, namely, ≥1 bacterial STI P12M, ≥10 male sex partners P6M, or HIV-PrEP use P6M, would substantially increase the proportion of all STI diagnoses potentially averted (60%) with minimal increase of the NNT (2.7).

This work informs on the impact of various doxy-PEP clinical prescribing criteria and demonstrates the benefit of focusing on any of the following three criteria: ≥1 bacterial STI P12M, ≥10 male sex partners P6M or HIV-PrEP use P6M.

Of 1.2 million children and young adolescents (

Decide TB is a pragmatic, hybrid effectiveness-implementation type 2 cluster-randomised trial with a stepped wedge design. The comprehensive TDA-based approach (intervention) will be implemented under programmatic conditions in four districts in each country (each comprising one DH and six PHCs), randomly selected to switch sequentially from the standard of care to the intervention. Evaluations will assess epidemiological, clinical, economic, social sciences, implementation and health policy endpoints. Aggregated and individual data from children with presumptive TB will be extracted from facility registers and individual data will be collected using an electronic medical record (EMR), both data sources will be entered in national Demographic Health Information System 2 databases. Questionnaires and individual/group interviews (among healthcare workers (HCWs), parents/caregivers and key informants), supervision and mentoring reports and quantitative cost tools will be used.

Ethics approval was obtained from national ethics committees in Mozambique (Instituto Nacional de Saúde review board and National Committee for Bioethics in Health) and Zambia (University of Zambia ethical review board and National Health Research Authority); this includes a waiver for analysing data collected by NTPs (no identifiable information reported, intervention with minimal risk) without individual consent from children’s parents/caregivers. Informed consent will be obtained from HCWs, parents/caregivers and key informants. Results will be openly shared with the scientific community, WHO and national and international stakeholders for translation into policy and practice. Procedures for requesting further use of Decide TB data will be publicly available.

NCT06593080; PACTR202407866544155.

Individuals with end-stage kidney disease (ESKD), whether receiving dialysis or conservative care, experience high symptom burden and limited life expectancy, indicating substantial palliative care needs. Integrating palliative care into kidney care is vital for comprehensive ESKD management, but access remains uneven across sociodemographic groups. Identifying and addressing these disparities is key to ensuring equitable care and improving patient outcomes. This study aims to explore sociodemographic factors associated with specialist palliative care utilisation among people with ESKD.

This study protocol outlines a scoping review of peer-reviewed and grey literature using an established methodological framework by the Joanna Briggs Institute (JBI), and reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Relevant literature will be identified through a multi-database (Ovid MEDLINE, Embase, CINAHL, PsycINFO) and grey literature search strategy designed alongside a health sciences librarian. To be included, articles must involve individuals with ESKD and report on how sociodemographic factors influence access to and utilisation of specialist palliative care services. Results of the search will be screened independently by two reviewers and data from included studies will be extracted independently and in duplicate. A narrative and thematic analysis will be conducted to identify key themes related to sociodemographic influences on specialist palliative care access and utilisation among individuals with ESKD, with particular attention to differences between kidney care modalities (dialysis vs conservative care) and the extent to which intersectionality of sociodemographic factors has been examined.

Ethics approval is not required for this scoping review. Findings will be submitted for publication in a peer-reviewed journal. Results will identify patient-related factors influencing access to specialist palliative care in ESKD and remaining gaps in the literature, informing future research and policy to support equitable care.

Insomnia disorder imposes a significant burden on children and adolescents; however, treatment options are limited. This paper describes the first controlled study to investigate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in children and adolescents with or without comorbid neurodevelopmental disorders, allowing its evaluation in a broad paediatric population.

This multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding Phase 2 trial includes male and female participants aged ≥10 to

This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site. Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal.

NCT05423717.

The hormone replacement drug levothyroxine is the most common therapy for people with reduced function of the thyroid gland. The optimal dosage varies considerably between individuals, and reaching the correct dosage is often a time-consuming task. To reduce the time needed for dose adjustments, we have developed a model for calculating each patient’s optimal dosage and an associated decision support tool (DST). We present the study protocol for a randomised controlled trial using the DST in initiation and adjustment of levothyroxine therapy for thyroidectomised patients. The aim of the study is to assess the tool’s efficacy on therapeutic target achievement and to investigate whether faster dose adjustments lead to better patient-reported outcomes on symptoms and health-related quality of life (HRQoL).

We will conduct a randomised, controlled, multicentre, non-blinded, parallel arm trial with three intervention groups and one control group. We will include 240 patients undergoing total or completion thyroidectomy in three Norwegian hospitals. Patients allocated to the three intervention groups will have the option to use the DST in dose adjustments after the operation. Each intervention group will test a different version of the DST. The control group will follow standard care practice. The randomisation ratio will be 1:1:1:1. Our primary outcome is proportion of patients within biochemical target at 8 weeks postoperatively. Secondary outcomes are distance from biochemical target at 8 weeks, mean time to achieve biochemical target, change in HRQoL, adverse events and number of days absence from work.

The study has been approved by the Norwegian Medical Products Agency (CIV-23-02-042436), The Norwegian Ethics Committee for Clinical Trials on Medicinal Products and Medical Devices (547311), and the patient protection officer at the University Hospital of North Norway. All participants will give written informed consent prior to inclusion. Results will be published open access in international peer-reviewed journals and communicated to the public through appropriate channels.

NCT06455371.

The length of hospital stay for patients with physical illnesses is longer for those with mental health comorbidity, particularly in the presence of severe physical multimorbidity. Integrating psychosocial risk screening at hospital admission, with a subsequent care pathway, could address psychosomatic and social care needs early and reduce length of stay. However, implementation may be hindered by organisational factors such as increased staff workload and timely integration into existing processes. In addition, patient factors such as low acceptance of screening and follow-up may affect uptake. This pilot study aims to assess the feasibility of implementing this integrated approach to screening and follow-up in preparation for a confirmatory trial.

The present study is a single centre, randomised feasibility study conducted on a pilot ward. Patients will be enrolled and assigned to the intervention or the control group. Only the intervention group will receive tablet-based psychosocial risk screening conducted by ward physicians or medical students in their practical year. If the psychosomatic screening is positive and the patient agrees, he or she is referred to the psychosomatic consultation service. If the social service screening is positive, the patient will be seen by a social worker. The main objective of this study is to assess the feasibility of conducting a full-sized confirmatory trial. An informed consent rate of 30% of eligible patients is set as the feasibility criterion. A study period of 4 months is planned for the feasibility study. The feasibility study will be analysed using descriptive statistics.

The study protocol was approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-301/2024) on 24 May 2024. The results of this feasibility study will be published in a peer-reviewed journal.

NCT06651164.

Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 14% of the French children. Topical treatments are restrictive, leading patients to seek alternative options. Medical hypnosis may be a therapeutic approach, providing hypno-analgesia through comfort and soothing of the skin as well as anxiolysis by managing stress and boosting self-esteem. To date, only five studies have explored medical hypnosis in AD, showing promising results but limited by small sample sizes and lack of control arms. This study protocol describes the methodology for an initial evaluation of medical hypnosis within a therapeutic patient education (TPE) programme, called Hypno-DA.

The Hypno-Atopic Dermatitis (Hypno-AD) study is a prospective, monocentric, non-blinded, parallel, cluster-randomised controlled trial conducted at the University Hospital of La Reunion, France. The study commenced on 13 August 2024 and is scheduled to conclude on 13 August 2026. The primary objective is to assess the feasibility of recruiting for a medical hypnosis programme for children with mild-to-severe AD. 32 patients (aged 8–17 years) will be randomly allocated in a 1:1 ratio to receive TPE sessions combined with medical hypnosis (experimental arm) or the usual TPE sessions performed for AD without medical hypnosis (control arm). The experimental arm will employ a hypnosis-based intervention, referred to as the ‘superhero costume’ technique. Reinforcement will be provided through the practice of self-hypnosis at home, guided by listening to an audio recording provided on a Universal Serial Bus (USB) key. Secondary outcomes will be assessed at 1-month, 3-month and 6-month post-randomisation. These will include compliance with the required practice of self-hypnosis at home, rate of loss of follow-ups, patient satisfaction, effectiveness of the hypnosis programme on the control of AD (ADCT) and severity of AD (Patient-Oriented SCORing Atopic Dermatitis) and the global impression parents may have concerning the changes in their child’s AD.

Ethics approval was obtained from the Ile de France I Research and Institutional Ethics Committee (No. 2022-A01153-40). All methods were carried out in accordance with French law No. 2012-300 (5 March 2012) related to research involving humans as well as Good Clinical Practices (International Council for Harmonisation (ICH) version 4 of 9 November 2016, and the decision of 24 November 2006). Methods will conform to the Declaration of Helsinki. Informed oral consent from at least one legal guardian of each participant will be obtained in addition to oral consent from the child. Results will be published in an indexed peer-reviewed journal as well as presented and disseminated at scientific conferences.

NCT05611346.

Informed consent is an essential component of surgical care; however, patients often struggle to fully understand procedures, associated risks and available alternatives. Factors such as preoperative anxiety, limited health literacy and the complexity of consent documents can further impair comprehension and information retention. The active informed consent (CIA) pathway, based on a Patient Educational Program that combines multimedia resources with a comprehension test, aims to enhance patient understanding, improve satisfaction and reduce medicolegal issues.

The study will be conducted as a multicentre, non-pharmacological, randomised controlled trial in three hospitals in the Emilia-Romagna region (Italy). A total of 300 patients undergoing elective complex spinal surgery or robotic radical prostatectomy will be enrolled and randomised (1:1) to the experimental arm or to the standard informed consent arm, using block randomisation stratified by centre. Outcomes will include patient satisfaction (Client Satisfaction Questionnaire), comprehension, psychological distress (Depression Anxiety Stress Scales), pain (Numeric Rating Scale), functional recovery (Oswestry Disability Index/International Prostate Symptom Score/International Consultation on Incontinence Questionnaire Short Form/International Index of Erectile Function) and medicolegal complaints. Assessments will be performed at baseline (T0), discharge (T1), 2 months (T2) and 6 months (T3), with extended monitoring of medicolegal outcomes for up to 5 years.

The study has been approved by the Regional Ethics Committee of Emilia-Romagna (protocol CIA21, V.1.3 dated 14 December 2022). Participation is voluntary and does not affect standard care. Results will be disseminated through peer-reviewed journals, conference presentations and communication with health authorities. If effective, the intervention may be implemented as a scalable model to improve patient empowerment and transparency in surgical consent.

NCT06059599.

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

NCT03963622.

Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.

This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.

The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.

ACTRN12624000408583.

The Shoulder Instability Registry (SIR) was established in 2019 to systematically capture and monitor outcomes following surgical treatment of shoulder instability (SI). The aim of this cohort profile is to describe the purpose, design, data structure and baseline characteristics of the SIR, and to outline how the registry supports longitudinal assessment of safety, functional recovery, quality of life and patient-reported outcomes after surgical treatment of SI.

The registry includes all patients treated surgically for SI. Data collection includes medical history of instability, surgical techniques and intraoperative findings. Clinical assessments include range of motion, instability-specific tests, hyperlaxity signs, Constant Score, subjective shoulder value and SI-specific scores such as the ROWE Score and the Western Ontario Shoulder Instability Index. Radiological evaluations included initial and follow-up imaging via X-rays and CT to assess bony lesions and SI-related arthropathy, as well as MRI for soft tissue injuries. Data are documented preoperatively, at 6 months and at 24 months postoperatively. Although the SIR is an observational cohort rather than a randomised clinical trial, treatment effectiveness is evaluated through longitudinal changes in validated patient-reported outcomes, clinical performance measures and imaging findings.

Between January 2019 and December 2024, 668 patients have been registered (mean age 31 years, 82% men, mean body mass index of 25). According to the American Association of Anesthesiology (ASA) Classification, 66% of patients were classified as ASA I, 33% as ASA II and only 1% as ASA III. 69% of admissions were due to accidents and 31% due to illness. Mean surgery duration was 75 min, and the median hospital stay was 2 days. 38% of patients were insured privately and had general insurance in 62%. 85% of cases were treated arthroscopically, and 15% were treated openly. Baseline clinical scores showed a mean Constant Score of 77 points, mean subjective shoulder value of 49%, mean ROWE Score of 46 points and mean Western Ontario Shoulder Instability Index of 53. Based on Gerber’s classification, 68% of cases were type B2, 29% B3, 2% B5 and fewer than 2% were classified as B4 or B1. 85% of cases suffered from anterior instability, while only 13% experienced posterior instability, the remaining 2% showed multidirectional instability. Among posterior cases, Moroder’s classification identified 58% as type B2, 19% as A2, 7% as A1, 6% as B1, 6% as C1 and 4% as C2. Regarding osteochondral lesions, 20% showed none, 31% showed a glenoid defect, 54% showed a Hill-Sachs lesion and 13% showed a cartilage defect. Scheibel’s classification identified glenoid defects as type 3a in 38% of cases, type 2 in 24%, type 1a in 13% of cases, type 3b in 11%, type 1b in 8% and type 1c in 5% of cases. Positive Gagey and Walch signs were observed in 29% and 27% of cases, respectively. Dislocations presented as primary events in 24% of cases, while 76% were recurrent. Surgical interventions included 459 (70%) Bankart repairs, 6 Bankart plus repairs (

We will continue prospectively enrolling and monitoring patients that receive surgical treatment of SI. There are no current plans to halt the data collection in the near future, thereby consistently increasing the number of patients in the registry. A larger availability of data will additionally allow us to apply machine learning modelling and develop risk-prediction tools with the goal of aiding surgical decision making.

Visual Patient Predictive (VPP) is an AI-based extension of the Visual Patient Avatar (VPA) that integrates deep learning models to predict upcoming vital sign deviations and display them as dashed visual elements. By explicitly showing anticipated changes, the system aims to support level 3 situation awareness—the projection of future patient states. This multicentre simulation study will evaluate whether predictive algorithms and visualisations integrated into the VPA (resulting in VPP) improve clinicians’ ability to anticipate critical vital sign changes compared with conventional number-based and waveform-based monitoring and examine its effects on decision-making, confidence, workload and user acceptance.

This investigator-initiated, randomised, within-subjects crossover, computer-based simulation trial will be conducted at five academic centres in Switzerland, Germany and the United States. Medical professionals from anaesthesiology departments will complete scenario-based prediction tasks using both VPP (as the index test) and conventional monitoring (as the reference standard) in randomised order, with the same participant evaluating both modalities and the identical underlying clinical scenario used in each condition, following video-based training and a learnability test. The primary outcome is recall (true positive rate) of vital sign deviation predictions. Secondary outcomes include average lead time, precision, prediction confidence, number and correctness of proposed interventions, perceived workload (NASA-TLX) and qualitative usability feedback. Quantitative data will be analysed using a logistic generalised linear mixed model with random intercepts for centre and participant, and a random slope for the intervention effect. Qualitative interviews will undergo thematic analysis.

The leading ethics committee (Zurich, Switzerland; BASEC-Req-2023–00465) reviewed and approved the study protocol. Ethics committees at the other participating centres have obtained their respective approvals or waivers. Bonn: 2025–144-BO, Boston: 2025P000501, Heidelberg: S-376/2025, Munich: 2025–357 W-CB. As this simulation study involves only healthcare professionals performing prediction tasks based on simulated vital sign scenarios—without collection of patient data or any medically relevant personal data—it does not constitute human subjects research under applicable regulations. Study results will be disseminated through peer-reviewed publications and presentations at scientific conferences.

The predictive value of carotid-femoral pulse wave velocity (cfPWV) for cardiovascular (CV) events in individuals with blood pressure (BP) 120–159/80–99 mm Hg, where more accurate risk stratification has the greatest clinical effect, is unknown. This study aims to determine whether cfPWV improves the prediction of CV events beyond traditional risk factors in individuals with moderate BP.

A systematic review and meta-analysis.

PubMed and EMBASE were searched through April 2023.

We included prospective, population-based cohort studies with ≥1 year follow-up that directly measured cfPWV as an index of arterial stiffness and reported incident CV disease (CVD), atherosclerotic CVD (ASCVD), coronary heart disease, stroke or all-cause mortality outcomes.

Individual participant data from 11 cohorts (n=15 987) were harmonised and analysed using two-stage random-effects meta-analysis. Incremental predictive and clinical utility analyses compared 10-year risk models with and without cfPWV.

There were 1279 first atherosclerotic CV events over a median follow-up of 9.9 years. A 1-SD increase in log_e(cfPWV) was associated with a 1.21-fold (95% CI 1.08 to 1.36) increase in risk of ASCVD. Adding cfPWV to traditional risk factors improved ASCVD prediction: change in discrimination (C-index): 0.0048 (95% CI 0.0002 to 0.0094), p=0.041. In hypothetical populations of 100 000 individuals with moderate BP, cfPWV-guided treatment could reduce event rates by 2.7% and 3.1% under European and US guidelines, respectively.

Adding cfPWV to traditional CV risk factors may improve the prediction and classification of first CV events in individuals with moderate BP. Additional screening with cfPWV could enhance risk stratification for antihypertensive treatment initiations.

Obstructive sleep apnoea syndrome (OSAS) co-occurs with major depressive disorder (MDD) in approximately 50% of cases, and this comorbidity is associated with greater severity of depressive symptoms, sleep disturbances and poorer clinical outcomes. Although continuous positive airway pressure (CPAP) therapy is effective in treating OSAS and alleviating symptoms of MDD, poor adherence during the initial weeks of treatment remains a major clinical challenge. Bright light therapy has been shown to rapidly improve sleep, wakefulness, cognitive function and mood in patients with MDD. Given these complementary mechanisms, we propose that combining CPAP with bright light therapy may enhance patient adherence during the critical initial phase of CPAP treatment, ultimately leading to better clinical and sleep-related outcomes.

In a single-centre, double-blind, sham-controlled study with two parallel arms, 130 patients with both MDD and OSAS requiring CPAP therapy will be randomly assigned to receive either 14 sessions of 30 min active bright light therapy (n=65, 1200 Lux, peak wavelength at 500 nm) or 14 sessions of 30 min sham bright light therapy (n=65, 33 Lux, peak wavelength at 600 nm) during the first 2 weeks, following CPAP initiation at home. The primary outcome will be adherence to CPAP (in hours per 24 hours during the 14 days of investigation). Secondary clinical outcomes will include changes in depressive and anxiety symptoms. Secondary sleep-related outcomes will include both objective sleep parameters (polysomnography, melatonin and actimetry) and standardised psychometric scales. The persistence of treatment effects at 1-month follow-up will also be evaluated.

The study was approved by an ethics committee (CPP Nord Ouest IV, Lille, France), and the French National Agency for Medicines and Health Products Safety registration number 2024-A01551-46. The findings will be disseminated through international peer-reviewed publications, presentations at scientific conferences and outreach at public conferences.

NCT06781593.