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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
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.
Centre Hospitalier le Vinatier
Bron, France, France
RECRUITINGCentre Hospitalier le Vinatier
Bron, France
NOT_YET_RECRUITINGCPAP Compliance
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)
Time frame: 1 time :Day 14
The maintenance of the effect ot the intervention will be measured 14 days before the interruption of light therapy at D28
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.
Time frame: 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
self-questionnaires form
\- ISI (Insomnia Severity Index): 0-7 (No insomnia), 8-14 (Sub-clinical insomnia), 15-21 (Clinical insomnia (moderate)), 22-28 (Clinical insomnia (severe))
Time frame: 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)
self-questionnaires form
\- PSQI (Pittsburgh Sleep Quality Index). Score has a possible range of 0-21 points. Actual scores ranged from 0 to 20 points, with an overall group mean of 7.4, median of 6.0, and SD of 5.1.
Time frame: 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)
self-questionnaires form
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\- PFS (Pichot Fatigue Scale): A total of more than 22, out of a maximum of 32, indicates excessive fatigue which should be investigated.
Time frame: 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)
self-questionnaires form
\- ESS (Epworth Sleepiness Scale): 0-5 (lower normal daytime sleepiness), 6-10 (normal daytime sleepiness), 11-12 (mild excessive daytime symptoms), 13-15 (moderate excessive daytime symptoms), 16-24 (severe excessive daytime symptom).
Time frame: 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)
self-questionnaires form
\- Beck (BDI-13): 0-4 (no depression), 4-7 (mild depression), 8-15 (moderate depression), 16 and over (severe depression)
Time frame: 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)
self-questionnaires form
\- HAD (Hospital Anxiety Depression Scale) anxiety section: 7 or less (no symptomatology), 8 to 10 (doubtful symptomatology), 11 and more (definite symptomatology)
Time frame: 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)
self-questionnaires form
\- Mac Nair Memory Complaint Scale (39 items rated from 0 to 4, i.e. from 0 to 156)
Time frame: 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)
self-questionnaires form
\- MCTQ (Munich Chronotype) Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotypes.
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Total sleep time in minutes.
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Sleep onset delay (in minutes).
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Time in bed in minutes.
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Sleep efficiency in percentage (TST on TPL)
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Sleep fragmentation in minutes (intra-sleep wake duration).
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Sleep onset latency.
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Motor activity in absolute value.
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Daily nap time in minutes.
Time frame: 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)
Actimetry results
Average of the following parameters over the different periods : \- Light exposure in lux.
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Delay in onset of REM sleep (in minutes).
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Amount of REM sleep (SP in minutes).
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Amount of deep slow wave sleep (SLP in minutes).
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Ratio (SLP + SP) / TST.
Time frame: 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)
polysomnography results, sleep architecture
Average of the following parameters over the different periods \- Arousal/microarousal index per hour.
Time frame: 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)