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

Queen's University

Status: Unknown

Conditions: Sleep Apnea, Obstructive; Depression

Treatments: Device: continuous positive airway pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT00441636

PSIY-247-06

Details and patient eligibility

About

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).

Full 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?

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

CPAP treatment

Experimental group

Description:

Continuous Positive Airway Pressure (CPAP)for 4 weeks

Treatment:

Device: continuous positive airway pressure (CPAP)

No CPAP

No Intervention group

Description:

routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures.

Control group

No Intervention group

Description:

No obstructive sleep apnea detected.