Depression, Sleep Apnea, Obstructive
Conditions
Keywords
depression, CPAP, obstructive sleep apnea
Brief summary
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
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: 1. How common is co-morbid OSA in patients with treatment resistant unipolar depression referred to a tertiary Mood Disorders Clinic? 2. 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? 3. What is the association between sleep fragmentation and hypoxemia and the severity of depression in patients with TRD?
Interventions
DEVICEcontinuous positive airway pressure (CPAP)
CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | baseline and 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Symbol digit modalities | baseline and 6 weeks | — |
| SF-36 questionnaire | baseline and 6 weeks | — |
| Profile of mood state (POMS) | baseline and 6 weeks | — |
| HAM-D21 | baseline and 6 weeks | Hamilton depression inventory |
| Beck Anxiety Inventory (BAI) | baseline and 6 weeks | — |
Countries
Canada
Contacts
Primary ContactRuzica Jokic, MD
Backup ContactGisele Berube
Outcome results
None listed