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Идёт набор NCT06781593

Combining Light Therapy and CPAP in Depression

Без фазы С лечением Major Depression Sleep Architecture Obstructive Sleep Apnea Compliance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Light therapy.
Кому может быть актуально
Состояния в реестре: Major Depression, Sleep Architecture, Obstructive Sleep Apnea, Compliance. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Light 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.

Первичные конечные точки

  • CPAP Compliance [Срок оценки: 1 time :Day 14]
Вторичные конечные точки (12)
  • The maintenance of the effect ot the intervention will be measured 14 days before the interruption of light therapy at D28 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Франция · 2 центра
  • Centre Hospitalier le Vinatier — Bron
  • Centre Hospitalier le Vinatier — Bron

Публикации

  • El Azzaoui H, Catoire S, Lecharpentier H, Felician J, Grasset O, Gronfier C, Vallet W, D'amato T, Brunelin J. Adjunctive bright light therapy to enhance continuous positive airway pressure adherence in patients with comorbid major depressive disorder and obstructive sleep apnoea syndrome: study protocol for a randomised sham-controlled trial. BMJ Open. 2025 Dec 15;15(12):e108669. doi: 10.1136/bmjo PMID 41401997

Идентификаторы

NCT: NCT06781593 · 2024-A01551-46

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗