Oropharyngeal Exercises and Post-Stroke Obstructive Sleep Apnea

NCT04212260 | Completed

• 1 other identifier: 313-2018
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the feasibility and effectiveness of an oropharyngeal exercise (O-PE) regimen in treating post-stroke obstructive sleep apnea, as an alternative therapy to continuous positive airway pressure (CPAP). Eligible patients will be randomized (1:1) to treatment using a pre-specified schedule of O-PEs vs. a sham control arm.

Conditions

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Stroke; Transient Ischemic Attack

Keywords

oropharyngeal exercises; obstructive sleep apnea; stroke; home sleep apnea test; randomized controlled trial; transient ischemic attack; feasibility; speech language pathology

Outcome Measures

Primary Outcomes (1)

• Percentage of enrolled participants completing >80% of the study exercises

  The study exercise regimen will be deemed feasible if \>80% of enrolled patients complete \>80% of the study exercises. Patient adherence with study exercises in both treatment arms will be recorded (in minutes) via use of the App that will deliver the oropharyngeal exercises/sham exercises. Completion of \>80% of the study exercises would be indicated by \>720 recorded minutes (if post-training visit is after 6 weeks) or \>1200 recorded minutes (if post-training visit is after 10 weeks).

  6-10 weeks (post-training)

Secondary Outcomes (10)

• OSA severity (as measured by the apnea-hypopnea index)

  Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)

• Lowest oxygen desaturation

  Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)

• Oro-pharyngeal deficits and dysarthria (as measured by the second version of Frenchay Dysarthria Assessment)

  Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)

• Tongue/lip/jaw weakness

  Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)

• Oro-facial kinematic capacity

  Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)

Study Arms (2)

Oro-pharyngeal exercises

EXPERIMENTAL

Use of oro-pharyngeal exercises

Behavioral: Oropharyngeal exercises

Sham control

SHAM COMPARATOR

Use of sham exercises.

Behavioral: Sham control

Interventions

Oropharyngeal exercises BEHAVIORAL

Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.

Oro-pharyngeal exercises

Sham control BEHAVIORAL

Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.

Sham control

Eligibility Criteria

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

You may qualify if:

• Imaging-confirmed stroke or stroke specialist-diagnosed transient ischemic attack (TIA)
• Prior diagnosis of OSA by a physician at any time in the past.
• Unable to tolerate CPAP after a 2-week trial of CPAP

You may not qualify if:

• BMI \> 40 kg/m2
• The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure.
• Oxygen therapy (e.g. nasal prongs), a nasogastric tube, or other medical device that would interfere with the placement of the home sleep apnea test
• Cranial malformations/nasal obstruction
• Significant depressive symptoms
• Regular use of hypnotic medications
• Other neuromuscular diseases or conditions affecting oropharyngeal muscles
• Montreal Cognitive Assessment (MoCA) \< 18
• Aphasia
• Oral or apraxia of speech

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Toronto Rehabilitation Institute: collaborator
• University of Toronto: collaborator
• Unity Health Toronto: collaborator
• Sunnybrook Research Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (19)

• Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26.

  PMID: 19101028 BACKGROUND

• Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

  PMID: 16282178 BACKGROUND

• Johnson KG, Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J Clin Sleep Med. 2010 Apr 15;6(2):131-7.

  PMID: 20411688 BACKGROUND

• Annoni JM, Staub F, Bogousslavsky J, Brioschi A. Frequency, characterisation and therapies of fatigue after stroke. Neurol Sci. 2008 Sep;29 Suppl 2:S244-6. doi: 10.1007/s10072-008-0951-0.

  PMID: 18690506 BACKGROUND

• Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012 Mar;11(3):209. doi: 10.1016/S1474-4422(12)70029-7. No abstract available.

  PMID: 22341029 BACKGROUND

• Martinez-Garcia MA, Soler-Cataluna JJ, Ejarque-Martinez L, Soriano Y, Roman-Sanchez P, Illa FB, Canal JM, Duran-Cantolla J. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Am J Respir Crit Care Med. 2009 Jul 1;180(1):36-41. doi: 10.1164/rccm.200808-1341OC. Epub 2009 Apr 30.

  PMID: 19406983 BACKGROUND

• Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1.

  PMID: 16141444 BACKGROUND

• Good DC, Henkle JQ, Gelber D, Welsh J, Verhulst S. Sleep-disordered breathing and poor functional outcome after stroke. Stroke. 1996 Feb;27(2):252-9. doi: 10.1161/01.str.27.2.252.

  PMID: 8571419 BACKGROUND

• Kaneko Y, Hajek VE, Zivanovic V, Raboud J, Bradley TD. Relationship of sleep apnea to functional capacity and length of hospitalization following stroke. Sleep. 2003 May 1;26(3):293-7. doi: 10.1093/sleep/26.3.293.

  PMID: 12749548 BACKGROUND

• Aaronson JA, Hofman WF, van Bennekom CA, van Bezeij T, van den Aardweg JG, Groet E, Kylstra WA, Schmand B. Effects of Continuous Positive Airway Pressure on Cognitive and Functional Outcome of Stroke Patients with Obstructive Sleep Apnea: A Randomized Controlled Trial. J Clin Sleep Med. 2016 Apr 15;12(4):533-41. doi: 10.5664/jcsm.5684.

  PMID: 26888587 BACKGROUND

• Ryan 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.

  PMID: 21372306 BACKGROUND

• McEvoy RD, Antic NA, Heeley E, Luo Y, Ou Q, Zhang X, Mediano O, Chen R, Drager LF, Liu Z, Chen G, Du B, McArdle N, Mukherjee S, Tripathi M, Billot L, Li Q, Lorenzi-Filho G, Barbe F, Redline S, Wang J, Arima H, Neal B, White DP, Grunstein RR, Zhong N, Anderson CS; SAVE Investigators and Coordinators. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. N Engl J Med. 2016 Sep 8;375(10):919-31. doi: 10.1056/NEJMoa1606599. Epub 2016 Aug 28.

  PMID: 27571048 BACKGROUND

• Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3.

  PMID: 15600056 BACKGROUND

• Chai-Coetzer CL, Luo YM, Antic NA, Zhang XL, Chen BY, He QY, Heeley E, Huang SG, Anderson C, Zhong NS, McEvoy RD. Predictors of long-term adherence to continuous positive airway pressure therapy in patients with obstructive sleep apnea and cardiovascular disease in the SAVE study. Sleep. 2013 Dec 1;36(12):1929-37. doi: 10.5665/sleep.3232.

  PMID: 24293768 BACKGROUND

• Colelli DR, Kamra M, Rajendram P, Murray BJ, Boulos MI. Predictors of CPAP adherence following stroke and transient ischemic attack. Sleep Med. 2020 Feb;66:243-249. doi: 10.1016/j.sleep.2018.10.009. Epub 2018 Oct 24.

  PMID: 30522873 BACKGROUND

• Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.

  PMID: 19234106 BACKGROUND

• Puhan MA, Suarez A, Lo Cascio C, Zahn A, Heitz M, Braendli O. Didgeridoo playing as alternative treatment for obstructive sleep apnoea syndrome: randomised controlled trial. BMJ. 2006 Feb 4;332(7536):266-70. doi: 10.1136/bmj.38705.470590.55. Epub 2005 Dec 23.

  PMID: 16377643 BACKGROUND

• Mackenzie C, Muir M, Allen C, Jensen A. Non-speech oro-motor exercises in post-stroke dysarthria intervention: a randomized feasibility trial. Int J Lang Commun Disord. 2014 Sep-Oct;49(5):602-17. doi: 10.1111/1460-6984.12096. Epub 2014 May 29.

  PMID: 24889103 BACKGROUND

• Kim HD, Choi JB, Yoo SJ, Chang MY, Lee SW, Park JS. Tongue-to-palate resistance training improves tongue strength and oropharyngeal swallowing function in subacute stroke survivors with dysphagia. J Oral Rehabil. 2017 Jan;44(1):59-64. doi: 10.1111/joor.12461.

  PMID: 27883209 BACKGROUND

MeSH Terms

Conditions

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Mark Boulos, MD MSc FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Yana Yunusova, MSc PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The parties involved consist of patients, sleep medicine team (includes sleep clinician and research personnel who collect/assess sleep data), and speech-language pathology team (research personnel who provide instructions on exercises and collect/assess speech data). All patients and members of the sleep medicine team will be masked to the condition assigned to each patient. The speech-language pathology team is not blinded to the patient assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 26, 2019
• Study Start: April 1, 2019
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)