Health TrialsbyHealthPanel

Combining Light Therapy and CPAP in Depression

ConditionsMajor DepressionSleep ArchitectureObstructive Sleep ApneaComplianceContinuous Positive Airway Pressure (CPAP)Light Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Active Light therapyActive comparator 1 intervention
Group B: Sham Light therapyPlacebo comparator 1 intervention

Trial outcomes

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)

Time frame
1 time :Day 14

Secondary outcomes

1

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
2

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)
3

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)
4

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.

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital le Vinatier

Lead sponsor

Source ClinicalTrials.gov
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