Recruiting

CPAP

Sponsor:

Queen's University

Code:

NCT00441636

Conditions

Depression

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

continuous positive airway pressure (CPAP)

Study Details

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).

Conditions

Depression

Sleep Apnea, Obstructive

Study ID

NCT00441636

Start date

Mar, 2007

Status verified date

Apr, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CPAP treatment

Continuous Positive Airway Pressure (CPAP)for 4 weeks

no intervention: No CPAP

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

no intervention: Control group

No obstructive sleep apnea detected.

Interventions

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

Primary outcome measure

  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline and 6 weeks ]

Central Contacts and Locations

Central contacts

Ruzica Jokic, MD

jokicr@pccchealth.org

Gisele Berube

berubeg@providencecare.ca

Locations

Providence Continuing Care Centre, Mental Health Services

Recruiting

Kingston, Ontario, Canada, K7L4X3

Principal Investigator:

Ruzica Jokic, MD

More Information

Sponsor

Queen's University

Last update posted

Apr 30, 2018

Last verified

Apr, 2018

Keywords

  • depression
  • CPAP
  • obstructive sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Queen's University on 2018-04-30.