Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00441636|
Recruitment Status : Recruiting
First Posted : March 1, 2007
Last Update Posted : April 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Sleep Apnea, Obstructive||Device: continuous positive airway pressure (CPAP)||Not Applicable|
What is the effect on mood and anxiety symptoms of adding CPAP to the psychiatric treatment of patients with TRD and associated OSA?
- 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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: CPAP treatment
Continuous Positive Airway Pressure (CPAP)for 4 weeks
Device: continuous 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
Other Name: CPAP - Respironics: RemStar plus M-series
No Intervention: No CPAP
routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.
No Intervention: Control group
No obstructive sleep apnea detected.
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 6 weeks ]
- Symbol digit modalities [ Time Frame: baseline and 6 weeks ]
- Stroop Test [ Time Frame: baseline and 6 weeks ]
- Trail-Making test [ Time Frame: baseline and 6 weeks ]
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline and 6 weeks ]
- Epworth Sleepiness Score (ESS) [ Time Frame: baseline and 6 weeks ]
- Beck Anxiety Inventory (BAI) [ Time Frame: baseline and 6 weeks ]
- SF-36 questionnaire [ Time Frame: baseline and 6 weeks ]
- Profile of mood state (POMS) [ Time Frame: baseline and 6 weeks ]
- HAM-D21 [ Time Frame: baseline and 6 weeks ]Hamilton depression inventory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441636
|Providence Continuing Care Centre, Mental Health Services||Recruiting|
|Kingston, Ontario, Canada, K7L4X3|
|Contact: Ruzica Jokic, MD|
|Principal Investigator: Ruzica Jokic, MD|
|Principal Investigator:||Ruzica Jokic, MD||Queen's University|