ApneaNCT04212260
Oropharyngeal Exercises and Post-Stroke Obstructive Sleep Apnea
A study testing Oropharyngeal exercises in people with Apnea and Sleep Apnea Syndromes, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- What is being tested?
- Oropharyngeal exercises
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 9 Dec 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- Other neuromuscular diseases or conditions affecting oropharyngeal muscles
- Montreal Cognitive Assessment (MoCA) < 18
- Aphasia
- Oral or apraxia of speech
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea After Stroke: A Randomized Feasibility Study
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.
Read the detailed description
BACKGROUND Obstructive sleep apnea (OSA) is characterized by recurrent obstruction of the upper airway during sleep due to intermittent loss of pharyngeal dilator muscle tone. OSA is both a risk factor for stroke, as well as a common post-stroke co-morbidity with approximately 72% of patients with stroke or transient ischemic attack (TIA) having OSA. Post-stroke OSA is linked to post-stroke, fatigue, which is a top research priority for stroke patients. Moreover, post-stroke OSA is associated with greater mortality, a higher risk of recurrent stroke, poorer cognition and lower functional status. In addition, stroke patients with OSA spend significantly longer times in rehabilitation and in acute care hospitals. Since OSA has a significant impact on the health of stroke patients, it is imperative that effective treatments are used to assist patients. Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with moderate to severe OSA. However, despite having been demonstrated to improve post-stroke cognition, motor and functional outcomes,and overall quality of life, rates of CPAP adherence are low. Reasons for poor post-stroke CPAP adherence are multi-factorial and often not easily modifiable. Overall, there is a major clinical need to develop an alternative effective and well-tolerated treatment for OSA.
Oro-pharyngeal exercises (O-PEs) are commonly used by speech-language pathologists to improve oro-motor strength and range of motion and serve as a promising alternative approach to treat OSA. For example, in a randomized controlled trial in which patients with moderate OSA underwent 3 months of daily exercises focusing on strengthening oro-pharyngeal musculature, OSA severity and symptoms were demonstrated to be significantly reduced compared to sham exercises.Similarly, use of the didgeridoo, a wind instrument that strengthens muscles of the upper airway, has also been demonstrated to reduce OSA severity.
METHODS Research Question: Is a randomized controlled trial (RCT) of an O-PE regimen in post-stroke OSA feasible?
Primary Objective: To examine whether an RCT of an O-PE regimen is feasible in stroke patients with OSA who are unable to tolerate CPAP. (i) The O-PE regimen will be considered feasible if >80% of enrolled patients complete >80% of the study exercises. (ii) We will also track the monthly number of eligible vs. recruited patients from Dr. Boulos' stroke and sleep disorders clinic. Hypothesis: An RCT of an O-PE regimen in post-stroke OSA will be feasible in that >80% of enrolled patients will complete >80% of the study exercises.
Secondary Objectives: To explore whether an O-PE regimen, compared to sham activities, might be effective in (i) improving various objective sleep metrics (i.e. OSA severity and nocturnal oxygen saturation), (ii) improving various measures of oropharyngeal physiology and function (i.e. oro-pharyngeal deficits and dysarthria, tongue/lip/jaw weakness, and oro-facial kinematics), and (iii) enhancing self-reported sleep-related symptoms. Hypothesis: Compared to the sham activities, O-PEs will positively influence the outcomes noted above.
- Being tested
- Oropharyngeal exercises, Sham control
- Keywords
- oropharyngeal exercises, obstructive sleep apnea, stroke, home sleep apnea test, randomized controlled trial, transient ischemic attack, feasibility, speech language pathology
- Medical subject headings
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal exercisesBehavioural
Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.
Sham controlBehavioural
Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.
| Study group | Role | What they receive |
|---|---|---|
| Oro-pharyngeal exercises | Experimental | Use of oro-pharyngeal exercises Receives: Behavioral: Oropharyngeal exercises |
| Sham control | Sham comparator | Use of sham exercises. Receives: Behavioral: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-10 weeks (post-training)
Secondary outcomes (10)
OSA severity (as measured by the apnea-hypopnea index)
Measured by the apnea-hypopnea index (AHI). AHI quantifies the number of apneas and hypopneas per hour of sleep. It will be measured using a home sleep monitor that has been validated for use in the stroke population.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Lowest oxygen desaturation
Lowest oxygen desaturation will be measured using a home sleep monitor that has been validated for use in the stroke population.
Measured: 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)
The second version of Frenchay Dysarthria Assessment (FDA-2) is divided into 7 sections: reflexes, respiration, lips, palate, laryngeal, tongue, and intelligibility, each containing several individual items. Each item is rated on a scale from "0" to "7", where "0" means normal for age, and "7" means unable to undertake task/movement/sound. The total score of the 7 sections will determine the severity of dysarthria.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Tongue/lip/jaw weakness
Measured by the Iowa Oral Performance Instrument \& Flexiforce (max pressure, endurance)
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Oro-facial kinematic capacity
Oro-facial kinematic capacity is defined by the range of facial motions (in mm) for lips and jaw, assessed during a standardized series of oro-motor tasks (e.g. Maximum mouth opening, syllable repetition)
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Functional status (as measured by Functional Outcomes of Sleep Questionnaire)
Functional Outcomes of Sleep Questionnaire (FOSQ) encompasses 5 subscales: activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome. An average score is calculated for each subscale and the 5 subscales are totaled to produce a total score. Subscale scores range from 1-4 with total scores ranging from 5-20. Higher scores indicate better functional status.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Daytime sleepiness (as measured by Epworth Sleepiness Scale)
Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Fatigue (as measured by Fatigue Severity Scale)
Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle. Scores range from 9 to 63, with higher scores indicating greater fatigue severity.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Quality of Life (as measured by Stroke Impact Scale)
Stroke Impact Scale (SIS) assesses multidimensional stroke outcomes through 8 domains: strength (raw score range: 4-20), hand function (5-25), activities of daily living (score range 10-50), mobility (score range 9-45), communication (score range 7-35), emotion (score range 9-45), memory and thinking (score range: 7-35), and participation (8-40). Each domain is scored separately. For each domain, raw scores are transformed using the following formula: Transformed Scale = (Actual raw score - lowest possible raw score)*100 / (Possible raw score range). Higher scores indicate greater quality of life.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Cognitive ability (as measured by Montreal Cognitive Assessment)
Montreal Cognitive Assessment (MoCA) is a screening test for detecting cognitive impairment. Scores range from 0 to 30, with higher scores indicating greater cognitive ability.
Measured: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Apr 2019
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Rehabilitation Institute, University of Toronto, Unity Health Toronto, Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Mark Boulos, MD MSc FRCPC, Principal investigator, Sunnybrook Health Sciences CentreYana Yunusova, MSc PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212260
- Sponsor's protocol ID
- 313-2018
- Status last verified
- Apr 2023
- First submitted
- 17 Dec 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19101028Yaggi 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.
PubMed 16282178Johnson 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.
PubMed 20411688Annoni 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.
PubMed 18690506Pollock 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.
PubMed 22341029Martinez-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.
PubMed 19406983Arzt 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.
PubMed 16141444Good 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.
PubMed 8571419Kaneko 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.
PubMed 12749548Aaronson 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.
PubMed 26888587Ryan 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 21372306McEvoy 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.
PubMed 27571048Aloia 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.
PubMed 15600056Chai-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.
PubMed 24293768Colelli 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.
PubMed 30522873
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Oropharyngeal Muscles as a Novel Approach to Treat Obstructive Sleep Apnea After Stroke: A Randomized Feasibility Study
- ClinicalTrials.gov ID
- NCT04212260
- Acronym / sponsor ID
- 313-2018
- Keywords
- oropharyngeal exercises, obstructive sleep apnea, stroke, home sleep apnea test, randomized controlled trial, transient ischemic attack, feasibility, speech language pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Toronto Rehabilitation Institute, University of Toronto, Unity Health Toronto, Sunnybrook Research Institute
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 26 Dec 2019 (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.
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.
Detailed description
BACKGROUND Obstructive sleep apnea (OSA) is characterized by recurrent obstruction of the upper airway during sleep due to intermittent loss of pharyngeal dilator muscle tone. OSA is both a risk factor for stroke, as well as a common post-stroke co-morbidity with approximately 72% of patients with stroke or transient ischemic attack (TIA) having OSA. Post-stroke OSA is linked to post-stroke, fatigue, which is a top research priority for stroke patients. Moreover, post-stroke OSA is associated with greater mortality, a higher risk of recurrent stroke, poorer cognition and lower functional status. In addition, stroke patients with OSA spend significantly longer times in rehabilitation and in acute care hospitals. Since OSA has a significant impact on the health of stroke patients, it is imperative that effective treatments are used to assist patients. Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with moderate to severe OSA. However, despite having been demonstrated to improve post-stroke cognition, motor and functional outcomes,and overall quality of life, rates of CPAP adherence are low. Reasons for poor post-stroke CPAP adherence are multi-factorial and often not easily modifiable. Overall, there is a major clinical need to develop an alternative effective and well-tolerated treatment for OSA.
Oro-pharyngeal exercises (O-PEs) are commonly used by speech-language pathologists to improve oro-motor strength and range of motion and serve as a promising alternative approach to treat OSA. For example, in a randomized controlled trial in which patients with moderate OSA underwent 3 months of daily exercises focusing on strengthening oro-pharyngeal musculature, OSA severity and symptoms were demonstrated to be significantly reduced compared to sham exercises.Similarly, use of the didgeridoo, a wind instrument that strengthens muscles of the upper airway, has also been demonstrated to reduce OSA severity.
METHODS Research Question: Is a randomized controlled trial (RCT) of an O-PE regimen in post-stroke OSA feasible?
Primary Objective: To examine whether an RCT of an O-PE regimen is feasible in stroke patients with OSA who are unable to tolerate CPAP. (i) The O-PE regimen will be considered feasible if >80% of enrolled patients complete >80% of the study exercises. (ii) We will also track the monthly number of eligible vs. recruited patients from Dr. Boulos' stroke and sleep disorders clinic. Hypothesis: An RCT of an O-PE regimen in post-stroke OSA will be feasible in that >80% of enrolled patients will complete >80% of the study exercises.
Secondary Objectives: To explore whether an O-PE regimen, compared to sham activities, might be effective in (i) improving various objective sleep metrics (i.e. OSA severity and nocturnal oxygen saturation), (ii) improving various measures of oropharyngeal physiology and function (i.e. oro-pharyngeal deficits and dysarthria, tongue/lip/jaw weakness, and oro-facial kinematics), and (iii) enhancing self-reported sleep-related symptoms. Hypothesis: Compared to the sham activities, O-PEs will positively influence the outcomes noted above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oro-pharyngeal exercises | Experimental | Behavioral: Oropharyngeal exercisesUse of oro-pharyngeal exercises |
| Sham control | Sham comparator | Behavioral: Sham controlUse of sham exercises. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Oropharyngeal exercisesOro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app. | Behavioural | Oro-pharyngeal exercises |
| Sham controlSimple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app. | Behavioural | Sham control |
Primary outcome
Percentage of enrolled participants completing >80% of the study exercises
Time frame: 6-10 weeks (post-training)
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).
10 secondary outcomes
OSA severity (as measured by the apnea-hypopnea index)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Lowest oxygen desaturation
Time frame: 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)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Tongue/lip/jaw weakness
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Oro-facial kinematic capacity
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Functional status (as measured by Functional Outcomes of Sleep Questionnaire)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Daytime sleepiness (as measured by Epworth Sleepiness Scale)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Fatigue (as measured by Fatigue Severity Scale)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Quality of Life (as measured by Stroke Impact Scale)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
Cognitive ability (as measured by Montreal Cognitive Assessment)
Time frame: Baseline, 6-10 weeks (post-training), and 10-14 weeks (retention)
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 14 Apr 2023.
- Background: PubMed 19101028Bradley 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.
- Background: PubMed 16282178Yaggi 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.
- Background: PubMed 20411688Johnson 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.
- Background: PubMed 18690506Annoni 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.
- Background: PubMed 22341029Pollock 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.
- Background: PubMed 19406983Martinez-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.
- Background: PubMed 16141444Arzt 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.
- Background: PubMed 8571419Good 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.
- Background: PubMed 12749548Kaneko 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.
- Background: PubMed 26888587Aaronson 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.
- Background: 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.
- Background: PubMed 27571048McEvoy 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.
- Individual participant dataSharing planned: No
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Obstructive Sleep Apnea
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.
Mark Boulos, MD MSc FRCPC principal investigator
Sunnybrook Health Sciences Centre
Yana Yunusova, MSc PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal exercises in people with Apnea and Sleep Apnea Syndromes, 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 3 inclusion and 10 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 14 Apr 2023. 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. Some participants in this study may receive a placebo. 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 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?
Percentage of enrolled participants completing >80% of the study exercises (time frame: 6-10 weeks (post-training)). 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 NCT04212260, which also lists 19 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 14 Apr 2023.