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

Primary Purpose

Depression, Sleep Apnea, Obstructive

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

continuous positive airway pressure (CPAP)

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, CPAP, obstructive sleep apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Providence Continuing Care Centre, Mental Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

CPAP treatment

No CPAP

Control group

Arm Description

Continuous Positive Airway Pressure (CPAP)for 4 weeks

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

No obstructive sleep apnea detected.

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Symbol digit modalities

Stroop Test

Trail-Making test

Pittsburgh Sleep Quality Index (PSQI)

Epworth Sleepiness Score (ESS)

Beck Anxiety Inventory (BAI)

SF-36 questionnaire

Profile of mood state (POMS)

HAM-D21

Hamilton depression inventory

Full Information

NCT ID

NCT00441636

First Posted

February 27, 2007

Last Updated

April 27, 2018

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT00441636

Brief Title

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

Official Title

Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Sleep Apnea, Obstructive

Keywords

depression, CPAP, obstructive sleep apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CPAP treatment

Arm Type

Experimental

Arm Description

Continuous Positive Airway Pressure (CPAP)for 4 weeks

Arm Title

No CPAP

Arm Type

No Intervention

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

No obstructive sleep apnea detected.

Intervention Type

Device

Intervention Name(s)

continuous positive airway pressure (CPAP)

Other Intervention Name(s)

CPAP - Respironics: RemStar plus M-series

Intervention Description

CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist

Primary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale (MADRS)

Time Frame

baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Symbol digit modalities

Time Frame

baseline and 6 weeks

Title

Stroop Test

Time Frame

baseline and 6 weeks

Title

Trail-Making test

Time Frame

baseline and 6 weeks

Title

Pittsburgh Sleep Quality Index (PSQI)

Time Frame

baseline and 6 weeks

Title

Epworth Sleepiness Score (ESS)

Time Frame

baseline and 6 weeks

Title

Beck Anxiety Inventory (BAI)

Time Frame

baseline and 6 weeks

Title

SF-36 questionnaire

Time Frame

baseline and 6 weeks

Title

Profile of mood state (POMS)

Time Frame

baseline and 6 weeks

Title

HAM-D21

Description

Hamilton depression inventory

Time Frame

baseline and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruzica Jokic, MD

jokicr@pccchealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Gisele Berube

berubeg@providencecare.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruzica Jokic, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Continuing Care Centre, Mental Health Services

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L4X3

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruzica Jokic, MD

First Name & Middle Initial & Last Name & Degree

Ruzica Jokic, MD

12. IPD Sharing Statement

Learn more about this trial

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

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