This trial protocol will test whether improves early adherence in patients with both MDD and OSAS.
Evidence
The evidence is a single-centre, double-blind, sham-controlled randomised protocol assigning 130 patients to 14 active or sham bright light sessions during the first 2 weeks after home CPAP initiation.
Caveat
The protocol has no outcome data yet, and its planned effect assessment is limited to early adherence and 1-month follow-up at one centre.
Simplified
INTRODUCTION: 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 (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. 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.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT06781593.
Key numbers
130
Participants
Total number of patients enrolled in the trial.
14
Sessions of Therapy
Number of sessions for both active and sham .
0.5
Hours of Use
Expected difference in mean adherence between active and sham groups.
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Competing interests: HEA received financial support in the form of a PhD fellowship from Linde Homecare France. OG is affiliated with Linde Homecare France. All the other authors declare no competing interests.
