Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)

Study Overview
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Brief Summary
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The purpose of the study is to determine the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD (treatment resistant depression) and associated OSA (obstructive sleep apnea).

Detailed Description
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Primary objective: What is the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD and associated OSA? Secondary objectives: How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic? Is there a difference in daytime functioning (severity of depressive and anxiety symptoms, cognitive function, daytime sleepiness) and sleep quality between patients with TRD diagnosed with OSA compared with patients with TRD who have no OSA? What is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with TRD?

Official Title
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Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

Conditions
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Depression, Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with TRD. Males and females between the ages of 18 and 65 years who agree to take part and sign the Informed Consent will be invited to participate in the study. Patients with co-morbid Dysthymic Disorder, Generalized Anxiety Disorder or Social Anxiety Disorder may be included in the study. Exclusion Criteria: Patients with uncontrolled medical illnesses will not be permitted to participate. Patients with a history of current or Bipolar Disorder, Schizophrenia, Panic Disorder, Obsessive-Compulsive Disorder or Anorexia Nervosa. Head injury patients resulting in loss of consciousness for more than 10 minutes. Patients with epilepsy or severe personality disorders who, at the judgment of the investigators, are not appropriate candidates for the study, will be excluded. Patients who do not have the mental or physical capacity to apply the CPAP interface and to plug in and switch on an auto CPAP unit at home will be excluded. Blind and/or deaf patients will be excluded. Patients who initially decline an offer of CPAP treatment for OSA, and those who prefer conservative treatment options (weight loss, avoidance of alcohol and sedatives) will be excluded. Patients with severe claustrophobia, who cannot tolerate any CPAP interface, will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>Continuous Positive Airway Pressure (CPAP)for 4 weeks | Device: continuous positive airway pressure (CPAP)<br>* CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist<br>* Other names: CPAP - Respironics: RemStar plus M-series;|
| No Intervention: No CPAP<br>routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures. | |
| No Intervention: Control group<br>No obstructive sleep apnea detected. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) |  | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symbol digit modalities |  | baseline and 6 weeks | 
| Stroop Test |  | baseline and 6 weeks | 
| Trail-Making test |  | baseline and 6 weeks | 
| Pittsburgh Sleep Quality Index (PSQI) |  | baseline and 6 weeks | 
| Epworth Sleepiness Score (ESS) |  | baseline and 6 weeks | 
| Beck Anxiety Inventory (BAI) |  | baseline and 6 weeks | 
| SF-36 questionnaire |  | baseline and 6 weeks | 
| Profile of mood state (POMS) |  | baseline and 6 weeks | 
| HAM-D21 | Hamilton depression inventory | baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, CPAP, obstructive sleep apnea