Compliance, Continuous Positive Airway Pressure (CPAP), Light Therapy, Major Depression, Obstructive Sleep Apnea, Sleep Architecture
Conditions
Brief summary
In a double-blind, parallel-group controlled trial, we aim to measure the effect of two weeks of light therapy combined with the CPAP on compliance CPAP in patients with major depressive disorder.
Detailed description
Major depressive disorder (MDD) is a frequent and disabling psychiatric condition. Clinically, MDD is characterized by persistent depressed mood, loss of interest, loss of pleasure in daily activities, and sleep disturbance. The link between sleep disturbance and depressive symptoms is complex and bidirectional, but data from the literature suggest that treatment of sleep disturbance in patients with MDD is associated with a better prognosis and a reduction in the number of relapses. Among sleep disorders, obstructive sleep apnea syndrome (OSAS) is a frequent comorbidity in MDD. The severity of OSAS correlates with the severity of depressive symptoms, and treatment of OSAS with continuous positive airway pressure (CPAP) can reduce daytime sleepiness and some depressive symptoms. Despite its efficacy, CPAP treatment is often poorly tolerated by patients, and compliance rates are often low, with discontinuation of treatment within the first 15 days of initiation, before it has had a chance to demonstrate its effectiveness. Light therapy is a non-invasive medical device that has been shown to rapidly reduce certain depressive symptoms, such as insomnia. The aim of the study is to investigate whether the combination of two weeks of active light therapy with the introduction of CPAP can increase CPAP compliance at two weeks of treatment (D14) in patients with MDD and OSAS. To this end, 130 patients with MDD (MADRS \> 15) will be recruited and randomized to two intervention groups: one group receiving active light therapy combined with CPAP and one group receiving sham light therapy combined with CPAP. The study will take place in the patient's home. The company's service providers, accustomed to installing CPAP in patients' homes, will be responsible for delivering the light therapy glasses and actimetry watches at the end of the 2-week treatment period. A polysomnography recording will be acquired prior to treatment. Quality and compliance measurements are recorded by the CPAP machines and will be statistically analyzed. The investigators hypothesize that the early combination of active light therapy and CPAP will enable changes in CPAP complance, MDD symptoms severity, and sleep quality in patients with MDD and OSAS.
Interventions
DEVICELight therapy
The intervention consists of 30 minutes of daily exposure to light therapy glasses (active or sham according to randomization) on waking for 2 weeks. The light therapy will be delivered in the patient's home at the same time as CPAP is introduced.
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sham light therapy consists of using a device similar to the active condition (glasses) but delivering a weakened version of the active light (addition of a filter and reduction of light intensity), emitting an intensity of 33 lux and a light spectrum (600 nm).
Intervention model description
This is a randomized sham controlled clinical trial, single center, double-blind, parallel group-controlled two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults consulting at the MICHEL JOUVET unit, CH Le Vinatier, Bron * Adults with a diagnosis of major depressive episode (DSM-V) and with a MADRS score ≥ 15 * Adults with a diagnosis of OSAS on ventilatory polygraphy or polysomnography (AASM 2017 criteria) requiring CPAP.
Exclusion criteria
* Refusal to participate. * Pregnant and breast-feeding women * Under guardianship or curatorship. * Unstable psychiatric or physical pathology (e.g., hypomania, high suicidal risk) considered incompatible with the study by the investigators. * Other psychiatric, neurologic or somatic conditions * Contraindication to light therapy: retinopathy, retinitis pigmentosa, diabetic retinopathy, macular degeneration, glaucoma, recent eye surgery (less than 3 months). patient wishing to choose a provider other than the protocol provider. * Patient wishing to choose a device other than SEFAM's S-BOX or a mask other than the nasal mask at the time of introduction. * Nasal obstruction. * Refusal to use actimetry, refusal to use light therapy, refusal to use CPAP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Compliance | 1 time :Day 14 | CPAP compliance will be measured via CPAP reports on manufacturers' websites. Analysis of time spent with CPAP per night of sleep (with a cut off score set at 4 hours or more per night = compliant patient) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maintenance of the effect ot the intervention will be measured 14 days before the interruption of light therapy at D28 | 3 times :The MADRS score will be measured during the inclusion visit (Day 7) and at Day 28, 14 days after the stop of light therapy | MADRS, is a standardized clinical scale used to assess the severity of depression in patients with mood disorders (score from 0 to over 34 = from healthy to severe depression). This hetero-questionnaire will be completed by a trained psychiatrisy during the inclusion visit and after the intervertion (D28). Analysis of the variation in the MADRS score makes it possible to determine the effect of light therapy on the evolution of the patient's depressive state. |
| self-questionnaires form | 3 times :Several self-questionnaires will be completed three times: at inclusion (Day 0), after 14 days (removal of light therapy glasses; Day 14) and at end-point (Day 28) | \- ISI (Insomnia Severity Index): 0-7 (No insomnia), 8-14 (Sub-clinical insomnia), 15-21 (Clinical insomnia (moderate)), 22-28 (Clinical insomnia (severe)) |
| Actimetry results | 3 times :average of different parameters over the periods before inclusion, from Day 7 to Day 0 (base line), period of treatment from Day 0 to Day 14 (CPAP and light therapy), period of CPAP without light therapy from Day14 to Day 28 (CPAP alone) | Average of the following parameters over the different periods : \- Total sleep time in minutes. |
| polysomnography results, sleep architecture | 2 times :baseline measure to control for OSAS diagnosis (performed between Day 30 and Day 1), and after intervention measure (post-PPC + light therapy at Day 28) | Average of the following parameters over the different periods \- Sleep onset delay (in minutes). |
Countries
France
Contacts
Primary ContactSébastien S CATOIRE, Dr
Backup ContactLydie L SARTELET, Mrs
Outcome results
None listed