Effects of Light Therapy on Compliance With Continuous Positive Airway Pressure in a Population of Depressed Patients Newly Fitted With Devices for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- CPAP Compliance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Light therapy
Active light therapy comes in the form of glasses and emits an intensity of 1200 Lux and a cyan-colored light spectrum (500nm), corresponding to a retinal exposure of 361.91uW/cm2 with a 30-min daily exposure upon waking for 2 weeks
干预措施: Light therapy (Device)
Sham Light therapy
Sham light therapy is the same device but in an attenuated version (addition of a filter and reduction of light intensity), emitting an intensity of 33 Lux and a light spectrum (600 nm) with a 30-min daily exposure upon waking for 2 weeks.
干预措施: Light therapy (Device)
结局指标
主要结局
CPAP Compliance
时间窗: 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)
次要结局
- 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))
- 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))
- 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))
- 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)