Positional Therapy to Treat Obstructive Sleep Apnea in Stroke Patients

NCT03558659 | Terminated

• 1 other identifier: 122-2018
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Ischemic; Obstructive Sleep Apnea

Keywords

Stroke; Obstructive sleep apnea; Positional therapy

Outcome Measures

Primary Outcomes (2)

• Change in obstructive sleep apnea severity (Apnea-hypopnea index)

  Apnea-hypopnea index will be measured using the Resmed ApneaLink device

  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

  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

  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)

  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)

  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

  Within 3-6 months of baseline

• Change in reaction time (psychomotor vigilance test)

  Baseline (within 1 week of study enrollment), follow-up 1 (within 2 weeks of baseline), follow-up 2 (within 3-6 months of baseline)

Study Arms (2)

Positional Therapy Belt

EXPERIMENTAL

Use of positional therapy belt (SlumberBUMP) during sleep.

Device: Positional therapy belt

Standard Care

NO INTERVENTION

No positional therapy belt provided for use during sleep.

Interventions

Positional therapy belt DEVICE

The positional therapy belt produced by SlumberBUMP will be used by stroke patients during sleep, which helps to avoid sleep in the supine position.

Also known as: SlumberBUMP positional therapy belt

Positional Therapy Belt

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke
• Patient has been treated at Sunnybrook Health Sciences Centre

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (8)

• 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.

  PMID: 27306393 BACKGROUND

• 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.

  PMID: 22336145 BACKGROUND

• 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.

  PMID: 21306949 BACKGROUND

• 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.

  PMID: 31041813 BACKGROUND

• 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.

  PMID: 20572416 BACKGROUND

• 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.

  PMID: 25040553 BACKGROUND

• 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.

  PMID: 27488603 BACKGROUND

• 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.

  PMID: 25669178 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Sleep Apnea, Obstructive; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 15, 2018
• Study Start: September 1, 2018
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)