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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

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
  1. 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.
  2. 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.
  3. 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.
  4. 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.

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 groups in NCT03558659
Study groupRoleWhat they receive
Positional Therapy BeltExperimentalUse of positional therapy belt (SlumberBUMP) during sleep.
Receives: Device: Positional therapy belt
Standard CareNo interventionNo 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.

  1. 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)

  2. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  1. First posted15 Jun 2018
  2. Study start1 Sep 2018
  3. Primary completion10 May 2022
  4. Study completion10 May 2022

Why it stopped: Low recruitment.

Resources

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)
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 27306393
  • Wallace 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 22336145
  • Svatikova 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 21306949
  • Srijithesh 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 31041813
  • Permut 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 20572416
  • Parra 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 25040553
  • Hermann 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 27488603
  • Aaronson 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

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.

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