Sleep Apnea, ObstructivePhase 3NCT00221065
Effect of Continuous Positive Airway Pressure (CPAP) on Cognitive and Functional Performance in Stroke Patients With Obstructive Sleep Apnea
A Phase 3 study testing Nasal Continuous positive airway pressure - Tyco 420G in people with Sleep Apnea, Obstructive and Cerebrovascular Accident, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
" Obstructive sleep apnea"(OSA) is a sleep breathing disorder. When a person with OSA tries to sleep the back of the throat closes and blocks the flow of air into lungs.When this happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not recognize). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Cerebrovascular Accident
- What is being tested?
- Nasal Continuous positive airway pressure - Tyco 420G
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Oct 2008
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completed embolic, thrombo-embolic or hemorrhagic subacute strokes admitted within 3 weeks of stroke onset to the SRU of TRI.
- all subjects must be able to follow simple commands in English based upon the Speech Language therapist's intake assessment and have competency to provide informed consent to participate in the study.
Who cannot join
- brainstem strokes due to increased aspiration risk with CPAP.
- patients with previously diagnosed OSA or stroke.
- diseases primarily or frequently affecting the central nervous system, including dementia, Parkinson's disease, multiple sclerosis,Huntington's disease or Lupus.
- history of a psychotic disorder
- stroke secondary to traumatic brain injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea
" Obstructive sleep apnea"(OSA) is a sleep breathing disorder. When a person with OSA tries to sleep the back of the throat closes and blocks the flow of air into lungs.When this happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not recognize). This occurs many times throughout the night, causing poor sleep quality,excessive daytime sleepiness, poor concentration, and sometimes depression.It is possible that poor outcomes observed in stroke patients with OSA result from these neurocognitive phenomena, presumably by reducing effective participation in rehabilitation activities.OSA is treated with nasal continuous positive airway pressure(CPAP).CPAP therapy keeps the back of the throat open so that airflow is never blocked.The study is designed to investigate whether treatment of OSA with CPAP improves the results of rehabilitation.
Read the detailed description
Stroke occurs as a result of ischemic injury to neural tissue, as a result of cardiogenic or artery to artery embolism or intracranial arterial thrombosis. The traditional vascular risk factors, namely hypertension, diabetes mellitus, tobacco smoking, family history and hyperlipidemia as well as atrial fibrillation are major determinants of stroke risk. Obstructive sleep apnea (OSA) has been shown to be a risk factor for hypertension and,although the association is less strong, atherosclerotic heart disease.There is a high prevalence of OSA amongst stroke patients, on the order of 60 to 70%, which is tenfold higher than in the general healthy population. Recently, it has been shown that, in stroke patients undergoing inpatient rehabilitation,the presence of OSA predicts both a poor functional outcome and greater length of hospitalization in the rehabilitation unit, even after adjustment for stroke severity.
We propose to examine the effect of CPAP therapy on the neuropsychological and functional outcomes of stroke patients with OSA admitted to the Toronto Rehabilitation Institute Stroke Rehabilitation Unit in a prospective, randomized study. We hypothesize that, in stroke patients with OSA, CPAP therapy will improve indices of vigilance, attention, and cognitive performances well as motor function(as it does in OSA patients without stroke)when compared to those not treated with CPAP. Furthermore,we hypothesize that the outcome of rehabilitation, as assessed by neuropsychological and motor indices, will be improved in these patients.
- Conditions
- Sleep Apnea, Obstructive, Cerebrovascular Accident
- Being tested
- Nasal Continuous positive airway pressure - Tyco 420G
- Keywords
- Sleep Apnea Syndromes, Cerebrovascular Accident
- Medical subject headings
- Sleep Apnea, Obstructive, Stroke, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Continuous positive airway pressure - Tyco 420GDevice
Also called Tyco CPAP machines 420 G
CPAP at determined pressure nightly for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Control |
| 2 | Experimental | CPAP Receives: Device: Nasal Continuous positive airway pressure - Tyco 420G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological and functional scales
Measured: 1 month
Secondary outcomes (6)
Measurements of severity of obstructive sleep apnea and sleep structure
Measured: 1 month
Epworth Sleepiness Scale
Measured: 1 month
Stanford Sleepiness Scale
Measured: 1 month
Participation Assessment Scale
Measured: 1 month
Neuropsychological tests(other than primary outcomes)
Measured: 1 month
Neurophysiological tests (other than primary outcomes)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Douglas T Bradley, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221065
- Sponsor's protocol ID
- TRI REB 04-043
- Other IDs
- TRI REB 04-043
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaneko Y, Floras JS, Usui K, Plante J, Tkacova R, Kubo T, Ando S, Bradley TD. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. N Engl J Med. 2003 Mar 27;348(13):1233-41. doi: 10.1056/NEJMoa022479.
PubMed 12660387Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.
PubMed 21372306
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of CPAP on Cognitive Function and Outcome of Stroke Patients With Obstructive Apnea
- ClinicalTrials.gov ID
- NCT00221065
- Acronym / sponsor ID
- TRI REB 04-043
- Conditions
- Sleep Apnea, Obstructive, Cerebrovascular Accident
- Keywords
- Sleep Apnea Syndromes, Cerebrovascular Accident
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jun 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Sep 2005 (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.
" Obstructive sleep apnea"(OSA) is a sleep breathing disorder. When a person with OSA tries to sleep the back of the throat closes and blocks the flow of air into lungs.When this happens, a person's sleep is disrupted, causing minor awakenings(which the individual may not recognize). This occurs many times throughout the night, causing poor sleep quality,excessive daytime sleepiness, poor concentration, and sometimes depression.It is possible that poor outcomes observed in stroke patients with OSA result from these neurocognitive phenomena, presumably by reducing effective participation in rehabilitation activities.OSA is treated with nasal continuous positive airway pressure(CPAP).CPAP therapy keeps the back of the throat open so that airflow is never blocked.The study is designed to investigate whether treatment of OSA with CPAP improves the results of rehabilitation.
Detailed description
Stroke occurs as a result of ischemic injury to neural tissue, as a result of cardiogenic or artery to artery embolism or intracranial arterial thrombosis. The traditional vascular risk factors, namely hypertension, diabetes mellitus, tobacco smoking, family history and hyperlipidemia as well as atrial fibrillation are major determinants of stroke risk. Obstructive sleep apnea (OSA) has been shown to be a risk factor for hypertension and,although the association is less strong, atherosclerotic heart disease.There is a high prevalence of OSA amongst stroke patients, on the order of 60 to 70%, which is tenfold higher than in the general healthy population. Recently, it has been shown that, in stroke patients undergoing inpatient rehabilitation,the presence of OSA predicts both a poor functional outcome and greater length of hospitalization in the rehabilitation unit, even after adjustment for stroke severity.
We propose to examine the effect of CPAP therapy on the neuropsychological and functional outcomes of stroke patients with OSA admitted to the Toronto Rehabilitation Institute Stroke Rehabilitation Unit in a prospective, randomized study. We hypothesize that, in stroke patients with OSA, CPAP therapy will improve indices of vigilance, attention, and cognitive performances well as motor function(as it does in OSA patients without stroke)when compared to those not treated with CPAP. Furthermore,we hypothesize that the outcome of rehabilitation, as assessed by neuropsychological and motor indices, will be improved in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Control |
| 2 | Experimental | Device: Nasal Continuous positive airway pressure - Tyco 420GCPAP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completed embolic, thrombo-embolic or hemorrhagic subacute strokes admitted within 3 weeks of stroke onset to the SRU of TRI.
- all subjects must be able to follow simple commands in English based upon the Speech Language therapist's intake assessment and have competency to provide informed consent to participate in the study.
Key exclusion criteria (5 listed)
- brainstem strokes due to increased aspiration risk with CPAP.
- patients with previously diagnosed OSA or stroke.
- diseases primarily or frequently affecting the central nervous system, including dementia, Parkinson's disease, multiple sclerosis,Huntington's disease or Lupus.
- history of a psychotic disorder
- stroke secondary to traumatic brain injury.
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 |
|---|---|---|
| Nasal Continuous positive airway pressure - Tyco 420GAlso: Tyco CPAP machines 420 GCPAP at determined pressure nightly for 1 month | Device | 2 |
Primary outcome
Neurological and functional scales
Time frame: 1 month
6 secondary outcomes
Measurements of severity of obstructive sleep apnea and sleep structure
Time frame: 1 month
Epworth Sleepiness Scale
Time frame: 1 month
Stanford Sleepiness Scale
Time frame: 1 month
Participation Assessment Scale
Time frame: 1 month
Neuropsychological tests(other than primary outcomes)
Time frame: 1 month
Neurophysiological tests (other than primary outcomes)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 12660387Kaneko Y, Floras JS, Usui K, Plante J, Tkacova R, Kubo T, Ando S, Bradley TD. Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. N Engl J Med. 2003 Mar 27;348(13):1233-41. doi: 10.1056/NEJMoa022479.
- Derived from this study: PubMed 21372306Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.
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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.
Douglas T Bradley, MD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nasal Continuous positive airway pressure - Tyco 420G in people with Sleep Apnea, Obstructive and Cerebrovascular Accident, run by Toronto Rehabilitation Institute 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 5 Feb 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological and functional scales (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221065, which also lists 2 linked publications.
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 5 Feb 2009.