Stroke, IschemicNCT03558659
Positional Therapy to Treat Obstructive Sleep Apnea in Stroke Patients
A study testing Positional therapy belt in people with Stroke, Ischemic and Obstructive Sleep Apnea, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Obstructive sleep apnea (OSA) has been found to be very common in stroke patients. Obstructive sleep apnea has been found to impede stroke rehabilitation and recovery. However, currently, there are few treatment options for OSA in stroke patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic, Obstructive Sleep Apnea
- What is being tested?
- Positional therapy belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 10 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute ischemic stroke
- Patient has been treated at Sunnybrook Health Sciences Centre
Who cannot join
- Patients who are unable to lie in a supine position (can be due to existing medical conditions)
- Patients who are using positive airway pressure therapy or supplemental oxygen at the time of the study
- Patients who are unable to use the portable sleep monitoring device
- Physical impairment, aphasia, language barrier, facial/bulbar weakness or trauma restricting the ability to use the portable sleep monitor, and absence of caregiver who can provide assistance
- Women who are pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positional Therapy to Treat Obstructive Sleep Apnea in Stroke Patients: A Randomized Controlled
Obstructive sleep apnea (OSA) has been found to be very common in stroke patients. Obstructive sleep apnea has been found to impede stroke rehabilitation and recovery. However, currently, there are few treatment options for OSA in stroke patients. Continuous positive airway pressure (CPAP) is the current therapy commonly used for OSA in the general population, however stroke patients are not highly compliant with this device. Therefore, we have decided to propose a more feasible alternative to treating obstructive sleep apnea through positional therapy. Positional therapy involves using a device to prevent patients from sleeping on their backs, since this position has been found to exacerbate obstructive sleep apnea. Therefore, we hypothesize that stroke patients who use the positional therapy belt will experience improvements in the severity of OSA.
Read the detailed description
- BACKGROUND Obstructive sleep apnea is very common in stroke patients, with reported prevalence rates between 30% and 70%. Recent studies suggest that it represents both a risk factor and a consequence of stroke and affects stroke recovery, outcome, and recurrence. A case-control study found that stroke patients with OSA had worse neurological status, lower functional independence scores, and a longer period of hospitalization than stroke patients without OSA. Furthermore, leaving OSA untreated after stroke affects rehabilitation efforts and short- and long-term stroke recovery and outcomes. Current literature supports the implementation of treatment protocols for OSA post-stroke in stroke units. This warrants the need to improve treatment of OSA in stroke patients as a means of secondary prevention and improvement of stroke outcomes. 1.1 Treating OSA in stroke patients Continuous positive airway pressure (CPAP) is the current gold standard therapy for OSA in the general population. Early CPAP therapy was found to have a positive effect on long-term survival in ischaemic stroke patients with moderate-severe OSA. However, CPAP is generally poorly tolerated by stroke patients and has a low compliance. Another alternative therapy, nasal expiratory positive airway pressure (EPAP), was also found to be an ineffective alternative to CPAP in acute stroke patients with OSA. Since sleeping in the supine position increases the chance of sleep apnea due to the tendency of the tongue to fall back and block the pharyngeal airway, having stroke patients sleep in a lateral position may improve OSA severity. As sleeping in the supine position is very common in acute stroke patients, positional therapy that reduces supine sleep may be beneficial in treating OSA in stroke patients. Positional therapy was found to be as effective as CPAP therapy in patients of the general population with positional OSA and in those patients who are intolerant to CPAP therapy. A pilot RCT found that positional therapy reduced the amount of supine positioning by 36% and AHI was reduced by 19.5% in stroke patients. Despite the modest improvements observed from position therapy in stroke patients, there is still a need for a vigorous randomized controlled trial to study the effectiveness of positional therapy to reduce the severity of OSA in stroke patients.
- RATIONALE It is of great importance to routinely diagnose and treat OSA after stroke because OSA is highly prevalent and influences rehabilitation and recovery efforts after stroke. Since CPAP, the current gold standard therapy for OSA, is poorly tolerated by stroke patients and is not conveniently accessible in the hospital, positional therapy for OSA may be a feasible alternative. Positional therapy belts have the advantages of being convenient for patients and may also be economically attractive, however they are not routinely used in Ontario hospital or clinics. Therefore, this warrants the investigation of the effectiveness and feasibility of positional therapy in stroke patients.
- SIGNIFICANCE Our project could substantially change the way healthcare is delivered for stroke patients if it finds that treating OSA with positional therapy improves clinical outcomes after stroke. Since CPAP, the current gold-standard for treating OSA, is poorly tolerated in stroke patients, positional therapy has the potential to provide therapy that is convenient and easy to use for stroke patients. Positional therapy devices can also be easily used in patient hospital beds or homes to treat their OSA. This novel approach would have the potential to improve patient outcomes while reducing healthcare spending and could be easily applied to settings outside of Sunnybrook HSC. Although our study will only examine stroke patients, future work could examine the role of positional therapy in other patient populations. Overall, our study will have an important impact on healthcare delivery and optimizing patient outcomes.
- RESEARCH OBJECTIVES
The primary objective of our randomized controlled trial is to determine whether positional therapy can effectively treat OSA in patients who have sustained a stroke. This will be evaluated by measuring OSA severity, as assessed by the apnea-hypopnea index (AHI) and oxygen desaturation. AHI and oxygen saturation are both measured using the Resmed ApneaLink device.
The secondary objectives include determining the effectiveness of positional therapy in reducing the time spent in the supine position during sleep. This will be measured using a portable body position sensor, available on the Resmed ApneaLink device. We will also assess if positional therapy improves actigraphy-derived measures (e.g. sleep efficiency and wake after sleep onset) by using Phillips Respironics actigraphy. Furthermore, we seek to explore whether positional therapy improves neurological outcomes (National Institutes of Health Stroke Scale, Montreal Cognitive Assessment, Modified Rankin), psychomotor outcomes (psychomotor vigilance test), psychosocial outcomes (depression, quality of life), performance of daily activities, daytime sleepiness, and length of stay in hospital.
- Conditions
- Stroke, Ischemic, Obstructive Sleep Apnea
- Being tested
- Positional therapy belt
- Keywords
- Stroke, Obstructive sleep apnea, Positional therapy
- Medical subject headings
- Ischemic Stroke, Sleep Apnea, Obstructive, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional therapy beltDevice
Also called SlumberBUMP positional therapy belt
The positional therapy belt produced by SlumberBUMP will be used by stroke patients during sleep, which helps to avoid sleep in the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Positional Therapy Belt | Experimental | Use of positional therapy belt (SlumberBUMP) during sleep. Receives: Device: Positional therapy belt |
| Standard Care | No intervention | No positional therapy belt provided for use during sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in obstructive sleep apnea severity (Apnea-hypopnea index)
Apnea-hypopnea index will be measured using the Resmed ApneaLink device
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in obstructive sleep apnea severity (oxygen desaturation)
Oxygen desaturation will be measured using the Resmed ApneaLink device
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Secondary outcomes (11)
Change in time spent in the supine position during sleep
Proportion of time spent on supine position during sleep will be measured using a portable body position sensor available on the Resmed ApneaLink device
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in sleep efficiency (actigraphy)
Sleep efficiency will be measured using Phillips Respironics actigraphy
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (National Institutes of Health Stroke Scale)
National Institutes of Health Stroke Scale will be used to measure impairment caused by a stroke. The score ranges from 0 to 42, with higher scores meaning greater stroke severity.
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Hospital length of stay
Hospital length of stay (number of days from time of stroke admission to discharge)
Measured: Within 3-6 months of baseline
Change in reaction time (psychomotor vigilance test)
Psychomotor vigilance will be assessed using a reaction-time test
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (Montreal Cognitive Assessment)
Neurological outcomes (Montreal Cognitive Assessment)
Measured: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in psychological outcomes (Centre for Epidemiological Studies Depression Scale)
Centre for Epidemiological Studies Depression Scale quantifies symptoms related to depression. Scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
Measured: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in quality of life (SF-12 quality of life questionnaire)
SF-12 quality of life questionnaire quantifies quality of life. Scores range from 12 to 47, with low scores indicating poorer quality of life.
Measured: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in daytime sleepiness (Epworth sleepiness scale)
Epworth sleepiness scale quantifies daytime sleepiness. Scores range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Measured: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (Modified Rankin scale)
Modified Rankin scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale ranges from 0-6, in which 0 indicates no disability or symptoms and 6 indicating death.
Measured: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in performance in activities of daily living (Barthel Index)
Barthel Index quantifies performance in activities of daily living. The scores range from 0 to 20, with lower scores indicating increased disability.
Measured: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Sep 2018
- Primary completion10 May 2022
- Study completion10 May 2022
Why it stopped: Low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark Boulos, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558659
- Sponsor's protocol ID
- 122-2018
- Status last verified
- May 2022
- First submitted
- 23 May 2018
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120.
PubMed 27306393Wallace DM, Ramos AR, Rundek T. Sleep disorders and stroke. Int J Stroke. 2012 Apr;7(3):231-42. doi: 10.1111/j.1747-4949.2011.00760.x. Epub 2012 Feb 15.
PubMed 22336145Svatikova A, Chervin RD, Wing JJ, Sanchez BN, Migda EM, Brown DL. Positional therapy in ischemic stroke patients with obstructive sleep apnea. Sleep Med. 2011 Mar;12(3):262-6. doi: 10.1016/j.sleep.2010.12.008.
PubMed 21306949Srijithesh PR, Aghoram R, Goel A, Dhanya J. Positional therapy for obstructive sleep apnoea. Cochrane Database Syst Rev. 2019 May 1;5(5):CD010990. doi: 10.1002/14651858.CD010990.pub2.
PubMed 31041813Permut I, Diaz-Abad M, Chatila W, Crocetti J, Gaughan JP, D'Alonzo GE, Krachman SL. Comparison of positional therapy to CPAP in patients with positional obstructive sleep apnea. J Clin Sleep Med. 2010 Jun 15;6(3):238-43.
PubMed 20572416Parra O, Sanchez-Armengol A, Capote F, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, Martinez-Null C, de la Pena M, Jimenez MC, Masa F, Casadon I, Alonso ML, Macarron JL. Efficacy of continuous positive airway pressure treatment on 5-year survival in patients with ischaemic stroke and obstructive sleep apnea: a randomized controlled trial. J Sleep Res. 2015 Feb;24(1):47-53. doi: 10.1111/jsr.12181. Epub 2014 Jul 21.
PubMed 25040553Hermann DM, Bassetti CL. Role of sleep-disordered breathing and sleep-wake disturbances for stroke and stroke recovery. Neurology. 2016 Sep 27;87(13):1407-16. doi: 10.1212/WNL.0000000000003037. Epub 2016 Aug 3.
PubMed 27488603Aaronson JA, van Bennekom CA, Hofman WF, van Bezeij T, van den Aardweg JG, Groet E, Kylstra WA, Schmand B. Obstructive Sleep Apnea is Related to Impaired Cognitive and Functional Status after Stroke. Sleep. 2015 Sep 1;38(9):1431-7. doi: 10.5665/sleep.4984.
PubMed 25669178
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positional Therapy to Treat Obstructive Sleep Apnea in Stroke Patients: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT03558659
- Acronym / sponsor ID
- 122-2018
- Conditions
- Stroke, Ischemic, Obstructive Sleep Apnea
- Keywords
- Stroke, Obstructive sleep apnea, Positional therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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) has been found to be very common in stroke patients. Obstructive sleep apnea has been found to impede stroke rehabilitation and recovery. However, currently, there are few treatment options for OSA in stroke patients. Continuous positive airway pressure (CPAP) is the current therapy commonly used for OSA in the general population, however stroke patients are not highly compliant with this device. Therefore, we have decided to propose a more feasible alternative to treating obstructive sleep apnea through positional therapy. Positional therapy involves using a device to prevent patients from sleeping on their backs, since this position has been found to exacerbate obstructive sleep apnea. Therefore, we hypothesize that stroke patients who use the positional therapy belt will experience improvements in the severity of OSA.
Detailed description
- BACKGROUND Obstructive sleep apnea is very common in stroke patients, with reported prevalence rates between 30% and 70%. Recent studies suggest that it represents both a risk factor and a consequence of stroke and affects stroke recovery, outcome, and recurrence. A case-control study found that stroke patients with OSA had worse neurological status, lower functional independence scores, and a longer period of hospitalization than stroke patients without OSA. Furthermore, leaving OSA untreated after stroke affects rehabilitation efforts and short- and long-term stroke recovery and outcomes. Current literature supports the implementation of treatment protocols for OSA post-stroke in stroke units. This warrants the need to improve treatment of OSA in stroke patients as a means of secondary prevention and improvement of stroke outcomes. 1.1 Treating OSA in stroke patients Continuous positive airway pressure (CPAP) is the current gold standard therapy for OSA in the general population. Early CPAP therapy was found to have a positive effect on long-term survival in ischaemic stroke patients with moderate-severe OSA. However, CPAP is generally poorly tolerated by stroke patients and has a low compliance. Another alternative therapy, nasal expiratory positive airway pressure (EPAP), was also found to be an ineffective alternative to CPAP in acute stroke patients with OSA. Since sleeping in the supine position increases the chance of sleep apnea due to the tendency of the tongue to fall back and block the pharyngeal airway, having stroke patients sleep in a lateral position may improve OSA severity. As sleeping in the supine position is very common in acute stroke patients, positional therapy that reduces supine sleep may be beneficial in treating OSA in stroke patients. Positional therapy was found to be as effective as CPAP therapy in patients of the general population with positional OSA and in those patients who are intolerant to CPAP therapy. A pilot RCT found that positional therapy reduced the amount of supine positioning by 36% and AHI was reduced by 19.5% in stroke patients. Despite the modest improvements observed from position therapy in stroke patients, there is still a need for a vigorous randomized controlled trial to study the effectiveness of positional therapy to reduce the severity of OSA in stroke patients.
- RATIONALE It is of great importance to routinely diagnose and treat OSA after stroke because OSA is highly prevalent and influences rehabilitation and recovery efforts after stroke. Since CPAP, the current gold standard therapy for OSA, is poorly tolerated by stroke patients and is not conveniently accessible in the hospital, positional therapy for OSA may be a feasible alternative. Positional therapy belts have the advantages of being convenient for patients and may also be economically attractive, however they are not routinely used in Ontario hospital or clinics. Therefore, this warrants the investigation of the effectiveness and feasibility of positional therapy in stroke patients.
- SIGNIFICANCE Our project could substantially change the way healthcare is delivered for stroke patients if it finds that treating OSA with positional therapy improves clinical outcomes after stroke. Since CPAP, the current gold-standard for treating OSA, is poorly tolerated in stroke patients, positional therapy has the potential to provide therapy that is convenient and easy to use for stroke patients. Positional therapy devices can also be easily used in patient hospital beds or homes to treat their OSA. This novel approach would have the potential to improve patient outcomes while reducing healthcare spending and could be easily applied to settings outside of Sunnybrook HSC. Although our study will only examine stroke patients, future work could examine the role of positional therapy in other patient populations. Overall, our study will have an important impact on healthcare delivery and optimizing patient outcomes.
- RESEARCH OBJECTIVES
The primary objective of our randomized controlled trial is to determine whether positional therapy can effectively treat OSA in patients who have sustained a stroke. This will be evaluated by measuring OSA severity, as assessed by the apnea-hypopnea index (AHI) and oxygen desaturation. AHI and oxygen saturation are both measured using the Resmed ApneaLink device.
The secondary objectives include determining the effectiveness of positional therapy in reducing the time spent in the supine position during sleep. This will be measured using a portable body position sensor, available on the Resmed ApneaLink device. We will also assess if positional therapy improves actigraphy-derived measures (e.g. sleep efficiency and wake after sleep onset) by using Phillips Respironics actigraphy. Furthermore, we seek to explore whether positional therapy improves neurological outcomes (National Institutes of Health Stroke Scale, Montreal Cognitive Assessment, Modified Rankin), psychomotor outcomes (psychomotor vigilance test), psychosocial outcomes (depression, quality of life), performance of daily activities, daytime sleepiness, and length of stay in hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positional Therapy Belt | Experimental | Device: Positional therapy beltUse of positional therapy belt (SlumberBUMP) during sleep. |
| Standard Care | No intervention | –No positional therapy belt provided for use during sleep. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute ischemic stroke
- Patient has been treated at Sunnybrook Health Sciences Centre
Key exclusion criteria (5 listed)
- Patients who are unable to lie in a supine position (can be due to existing medical conditions)
- Patients who are using positive airway pressure therapy or supplemental oxygen at the time of the study
- Patients who are unable to use the portable sleep monitoring device
- Physical impairment, aphasia, language barrier, facial/bulbar weakness or trauma restricting the ability to use the portable sleep monitor, and absence of caregiver who can provide assistance
- Women who are pregnant during the study period
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 |
|---|---|---|
| Positional therapy beltAlso: SlumberBUMP positional therapy beltThe positional therapy belt produced by SlumberBUMP will be used by stroke patients during sleep, which helps to avoid sleep in the supine position. | Device | Positional Therapy Belt |
Primary outcome
Change in obstructive sleep apnea severity (Apnea-hypopnea index)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Apnea-hypopnea index will be measured using the Resmed ApneaLink device
Change in obstructive sleep apnea severity (oxygen desaturation)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Oxygen desaturation will be measured using the Resmed ApneaLink device
11 secondary outcomes
Change in time spent in the supine position during sleep
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in sleep efficiency (actigraphy)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (National Institutes of Health Stroke Scale)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Hospital length of stay
Time frame: Within 3-6 months of baseline
Change in reaction time (psychomotor vigilance test)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (Montreal Cognitive Assessment)
Time frame: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in psychological outcomes (Centre for Epidemiological Studies Depression Scale)
Time frame: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in quality of life (SF-12 quality of life questionnaire)
Time frame: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in daytime sleepiness (Epworth sleepiness scale)
Time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)
Change in neurological outcomes (Modified Rankin scale)
Time frame: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Change in performance in activities of daily living (Barthel Index)
Time frame: Baseline (within 1 week of study enrollment), follow-up 2 (within 3-6 months of baseline)
Results and safety
The study was stopped early (reason given: Low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 27306393Wheeler NC, Wing JJ, O'Brien LM, Hughes R, Jacobs T, Claflin E, Chervin RD, Brown DL. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial. J Clin Sleep Med. 2016 Sep 15;12(9):1233-8. doi: 10.5664/jcsm.6120.
- Background: PubMed 22336145Wallace DM, Ramos AR, Rundek T. Sleep disorders and stroke. Int J Stroke. 2012 Apr;7(3):231-42. doi: 10.1111/j.1747-4949.2011.00760.x. Epub 2012 Feb 15.
- Background: PubMed 21306949Svatikova A, Chervin RD, Wing JJ, Sanchez BN, Migda EM, Brown DL. Positional therapy in ischemic stroke patients with obstructive sleep apnea. Sleep Med. 2011 Mar;12(3):262-6. doi: 10.1016/j.sleep.2010.12.008.
- Background: PubMed 31041813Srijithesh PR, Aghoram R, Goel A, Dhanya J. Positional therapy for obstructive sleep apnoea. Cochrane Database Syst Rev. 2019 May 1;5(5):CD010990. doi: 10.1002/14651858.CD010990.pub2.
- Background: PubMed 20572416Permut I, Diaz-Abad M, Chatila W, Crocetti J, Gaughan JP, D'Alonzo GE, Krachman SL. Comparison of positional therapy to CPAP in patients with positional obstructive sleep apnea. J Clin Sleep Med. 2010 Jun 15;6(3):238-43.
- Background: PubMed 25040553Parra O, Sanchez-Armengol A, Capote F, Bonnin M, Arboix A, Campos-Rodriguez F, Perez-Ronchel J, Duran-Cantolla J, Martinez-Null C, de la Pena M, Jimenez MC, Masa F, Casadon I, Alonso ML, Macarron JL. Efficacy of continuous positive airway pressure treatment on 5-year survival in patients with ischaemic stroke and obstructive sleep apnea: a randomized controlled trial. J Sleep Res. 2015 Feb;24(1):47-53. doi: 10.1111/jsr.12181. Epub 2014 Jul 21.
- Background: PubMed 27488603Hermann DM, Bassetti CL. Role of sleep-disordered breathing and sleep-wake disturbances for stroke and stroke recovery. Neurology. 2016 Sep 27;87(13):1407-16. doi: 10.1212/WNL.0000000000003037. Epub 2016 Aug 3.
- Background: PubMed 25669178Aaronson JA, van Bennekom CA, Hofman WF, van Bezeij T, van den Aardweg JG, Groet E, Kylstra WA, Schmand B. Obstructive Sleep Apnea is Related to Impaired Cognitive and Functional Status after Stroke. Sleep. 2015 Sep 1;38(9):1431-7. doi: 10.5665/sleep.4984.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positional therapy belt in people with Stroke, Ischemic and Obstructive Sleep Apnea, run by Sunnybrook Health Sciences Centre 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: stopped early, as of the sponsor's last update on 17 May 2022. 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?
The study was stopped early (reason given: Low recruitment.). Results are not available in the source record.
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?
Change in obstructive sleep apnea severity (Apnea-hypopnea index) (time frame: Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)). The study lists 2 primary outcomes in all. 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 NCT03558659, which also lists 8 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 17 May 2022.