Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)
NCT ID: NCT00441636
Last Updated: 2018-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2007-03-31
2019-12-31
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CPAP treatment
Continuous Positive Airway Pressure (CPAP)for 4 weeks
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
No CPAP
routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.
No interventions assigned to this group
Control group
No obstructive sleep apnea detected.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Queen's University
OTHER
Responsible Party
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Dr. Ruzica Jokic
Principal Investigator
Principal Investigators
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Ruzica Jokic, MD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Locations
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Providence Continuing Care Centre, Mental Health Services
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Ruzica Jokic, MD
Role: primary
Other Identifiers
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PSIY-247-06
Identifier Type: -
Identifier Source: org_study_id
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