Combining Light Therapy and CPAP in Depression (LUCIOPRESS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Major Depression; Compliance; Sleep Architecture; Light Therapy; Continuous Positive Airway Pressure (CPAP)
• Intervention / Treatment: Device: Light therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sébastien S CATOIRE, Dr; Phone Number: +33 +330437915495; Email: sebastien.catoire@ch-le-vinatier.fr
• Study Contact Backup: Name: Lydie L SARTELET, Mrs; Phone Number: +33 +33(0)437915531; Email: lydie.sartelet@ch-le-vinatier.fr

Study Locations

• France
  • Bron, France, 69678
    • Not yet recruiting
    • Centre Hospitalier Le Vinatier
  • Bron, France, 69678
    • Recruiting
    • Centre Hospitalier Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: 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.
Placebo Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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))	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.	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	- PFS (Pichot Fatigue Scale): A total of more than 22, out of a maximum of 32, indicates excessive fatigue which should be investigated.	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).	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)	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)	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)	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.	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.	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).	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.	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)	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).	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.	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.	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.	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.	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).	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).	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).	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.	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.	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)

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: Sébastien S CATOIRE, DR, Centre Hospitalier Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Mood Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Depression; Depressive Disorder; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2024-A01551-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No