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

Not Applicable

• Conditions: Depression; Sleep Apnea, Obstructive
• Interventions: Device: continuous positive airway pressure (CPAP)

• Registration Number: NCT00441636
• Lead Sponsor: Queen's University

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?

Study Timeline

• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-28
• Study Start: 2007-03
• Study First Posted: 2007-03-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP treatment	continuous positive airway pressure (CPAP)	Continuous Positive Airway Pressure (CPAP)for 4 weeks

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)	baseline and 6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Providence Continuing Care Centre, Mental Health Services; 🇨🇦 Kingston, Ontario, Canada