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

NCT ID: NCT00441636

Last Updated: 2018-04-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2019-12-31

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:

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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Depression Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CPAP treatment

Continuous Positive Airway Pressure (CPAP)for 4 weeks

Group Type EXPERIMENTAL

continuous positive airway pressure (CPAP)

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group

No obstructive sleep apnea detected.

Group Type NO_INTERVENTION

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

Intervention Type DEVICE

Other Intervention Names

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CPAP - Respironics: RemStar plus M-series

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ruzica Jokic

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ruzica Jokic, MD

Role: CONTACT

Gisele Berube

Role: CONTACT

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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