Combining Light Therapy and CPAP in Depression

NCT06781593 | Recruiting

• 1 other identifier: 2024-A01551-46
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression; Sleep Architecture; Obstructive Sleep Apnea; Compliance; Continuous Positive Airway Pressure (CPAP); Light Therapy

Outcome Measures

Primary Outcomes (1)

• CPAP 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)

  1 time :Day 14

Secondary Outcomes (23)

• 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

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Active Light therapy

ACTIVE COMPARATOR

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

Device: Light therapy

Sham Light therapy

PLACEBO COMPARATOR

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.

Device: Light therapy

Interventions

Light therapy DEVICE

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.

Active Light therapy; Sham Light therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (2)

Centre Hospitalier le Vinatier

Bron, France, 69678, France

RECRUITING

Centre Hospitalier le Vinatier

Bron, 69678, France

NOT YET RECRUITING

Related Publications (1)

• 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/bmjopen-2025-108669.

  PMID: 41401997 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Apnea, Obstructive; Patient Compliance

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sébastien S CATOIRE, DR

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien S CATOIRE, Dr

CONTACT

+330437915495; sebastien.catoire@ch-le-vinatier.fr

Lydie L SARTELET, Mrs

CONTACT

+33(0)437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized sham controlled clinical trial, single center, double-blind, parallel group-controlled two arms.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

FR (2)