Oropharyngeal Exercises to Treat Obstructive Sleep Apnea
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
The goal of this study is to determine whether a randomized controlled trial using oropharyngeal exercises to treat sleep apnea is feasible. Continuous positive airway pressure (CPAP) is the standard therapy for Obstructive sleep apnea (OSA), but it is poorly tolerated by many patients. Oropharyngeal exercises (OPEs) which are commonly used by speech-language pathologists to improve oro-motor strength, may serve as a promising alternative approach. The main questions this study aims to answer are:
* Is it feasible to use an oropharyngeal exercise protocol in patients with sleep apnea? * Will oropharyngeal exercises improve sleep apnea severity, daytime sleepiness, sleep quality, mood, workplace performance, and quality of life
Participants will be randomized into a supervised OPE intervention arm vs. unsupervised OPE intervention arm vs. sham treatment for a 10-week/5-day per week/two 20-minute session exercise protocol. The exercises will be administered via an app and the investigators will assess feasibility, as well as several sleep-related and oro-motor physiological outcomes before treatment, immediately post-treatment, and 4 weeks post-treatment. The investigators will use the results of this feasibility trial to inform the sample size needed for a larger clinical trial that will determine the efficacy of using oropharyngeal exercises to treat OSA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with OSA (defined as an apnea-hypopnea index ≥10/hr) in whom >50% of the respiratory events are obstructive in nature
Patients who are unwilling to use CPAP or have been unable to tolerate CPAP after at least a 2-week trial
Patients who are also not using an equipment-based treatment modality (e.g. PAP therapy, a dental appliance, or hypoglossal nerve stimulation) or surgery to manage their OSA.
Disqualifiers
Planned airway surgery, use of CPAP, a dental appliance, or other equipment-based treatment modality to manage OSA during the course of the study
Central respiratory events account for ≥50% of the overall apnea-hypopnea index
Reduced cognition (MoCA<18)
Any significant neurological condition that could impact oropharyngeal activity
Trial design
Design model
Parallel
Treatments tested in this trial
Oropharyngeal Exercises
BehavioralThe participant will practice exercises designed to strengthen the tongue and pharyngeal muscles
Sham Exercises
BehavioralThe participant will practice exercises that have no impact on oropharyngeal (e.g., base of the tongue) muscle strength.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Supervised Oropharyngeal ExercisesExperimental treatment 1 intervention
Group B: Unsupervised Oropharyngeal ExercisesActive comparator 1 intervention
Group C: Supervised Sham ExercisesSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of recruitment
The study team will maintain logs to track the number of patients screened, found to be eligible, and randomized into the trial; we will also track dropouts
Time frame
2 years2
Patient adherence with the study exercises
Patient adherence with the study exercises will be tracked (in minutes) by the OPEX app that will deliver the oropharyngeal/sham exercises. We will compute the percentage of exercises completed.
Time frame
10 weeks3
Ability to ascertain Obstructive Sleep Apnea (OSA) severity
Ability to ascertain OSA severity, as assessed by completion rates for the three home sleep apnea tests at baseline, post-training and retention. A home sleep apnea test will be considered "completed" if ≥4 hours of flow, effort, and oxygen evaluation are obtained. The cut-off of ≥4 hours was selected as it has been recommended by clinical practice guidelines and previously used in prior home sleep apnea test feasibility studies.
Time frame
14 weeksSecondary outcomes
1
Change in Obstructive Sleep Apnea (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.
Time frame
Baseline to 10 weeks (post-training) and 14 weeks (retention)2
Change in Lowest Oxygen Desaturation
Lowest oxygen desaturation will be measured using a home sleep monitor.
Time frame
Baseline to 10 weeks (post-training) and 14 weeks (retention)3
Change in Objective sleep quality
Objective sleep quality and quantity will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. Sleep efficiency will be calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes).
Time frame
Baseline to 10 weeks (post-training) and 14 weeks (retention)4
Change in Objective sleep quantity
Objective sleep quality will be assessed using wrist actigraphy that will be provided with the home sleep apnea test. The total sleep time will be calculated.
Time frame
Baseline to 10 weeks (post-training) and 14 weeks (retention)Sponsors and contacts
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Source ClinicalTrials.gov