DepressionNCT00441636
Treatment Resistant Depression and Obstructive Sleep Apnea, Effect of Continuous Positive Airway Pressure (CPAP)
A study testing continuous positive airway pressure (CPAP) in people with Depression and Sleep Apnea, Obstructive, run by Queen's University at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Sleep Apnea, Obstructive
- What is being tested?
- continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ruzica Jokic, MD contact
Gisele Berube contact
Canada1 site, 1 recruiting
- Recruiting
Providence Continuing Care Centre, Mental Health Services
Kingston, Ontario, K7L4X3
Ruzica Jokic, MD
Ruzica Jokic, MD
About this study
Official title: Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life
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).
Read the 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?
- Conditions
- Depression, Sleep Apnea, Obstructive
- Being tested
- continuous positive airway pressure (CPAP)
- Keywords
- depression, CPAP, obstructive sleep apnea
- Medical subject headings
- Depression, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Device
Also called CPAP - Respironics: RemStar plus M-series
CPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Continuous Positive Airway Pressure (CPAP)for 4 weeks Receives: Device: continuous positive airway pressure (CPAP) |
| No CPAP | No intervention | routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures. |
| Control group | No intervention | No obstructive sleep apnea detected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale (MADRS)
Measured: baseline and 6 weeks
Secondary outcomes (9)
Symbol digit modalities
Measured: baseline and 6 weeks
Stroop Test
Measured: baseline and 6 weeks
Trail-Making test
Measured: baseline and 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Measured: baseline and 6 weeks
Epworth Sleepiness Score (ESS)
Measured: baseline and 6 weeks
Beck Anxiety Inventory (BAI)
Measured: baseline and 6 weeks
SF-36 questionnaire
Measured: baseline and 6 weeks
Profile of mood state (POMS)
Measured: baseline and 6 weeks
HAM-D21
Hamilton depression inventory
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ruzica Jokic, Queen's University
- Investigators
- Ruzica Jokic, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441636
- Sponsor's protocol ID
- PSIY-247-06
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2007
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Resistant Depression and Obstructive Sleep Apnea: Effect of Treatment With CPAP on Mood, Anxiety and Quality of Life
- ClinicalTrials.gov ID
- NCT00441636
- Acronym / sponsor ID
- PSIY-247-06
- Conditions
- Depression, Sleep Apnea, Obstructive
- Keywords
- depression, CPAP, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: continuous positive airway pressure (CPAP)Continuous Positive Airway Pressure (CPAP)for 4 weeks |
| No CPAP | No intervention | –routine psychiatric care for 4 weeks followed by CPAP titration and initiation after followup measures. |
| Control group | No intervention | –No obstructive sleep apnea detected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous positive airway pressure (CPAP)Also: CPAP - Respironics: RemStar plus M-seriesCPAP (Respironics: RemStar plus M-series) machines for treatment of obstructive sleep apnea training for participant required by registered sleep technologist | Device | CPAP treatment |
Primary outcome
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: baseline and 6 weeks
9 secondary outcomes
Symbol digit modalities
Time frame: baseline and 6 weeks
Stroop Test
Time frame: baseline and 6 weeks
Trail-Making test
Time frame: baseline and 6 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline and 6 weeks
Epworth Sleepiness Score (ESS)
Time frame: baseline and 6 weeks
Beck Anxiety Inventory (BAI)
Time frame: baseline and 6 weeks
SF-36 questionnaire
Time frame: baseline and 6 weeks
Profile of mood state (POMS)
Time frame: baseline and 6 weeks
HAM-D21
Time frame: baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruzica Jokic, MD contact
Gisele Berube contact
Ruzica Jokic, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Depression and Sleep Apnea, Obstructive, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruzica Jokic, MD (jokicr@pccchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale (MADRS) (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.