Oropharyngeal Exercises to Treat Obstructive Sleep Apnea
Obstructive Sleep ApneaThe 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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* Use of medications that may impact tone of the upper airway (e.g. hypnotics, opiates) ≥3 nights per week during the 4 weeks prior to randomization
* Use of a medical device that would interfere with the use of the home sleep apnea test
* Plans to move to another city during the study that would impact compliance.
Lieu de l'étude
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
Contactez l'équipe d'étude
- Étude parrainée par
- Sunnybrook Health Sciences Centre
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05678088