ISRCTN13141364Active, not recruiting未知
Strengthening oropharyngeal muscles as a novel approach to treat obstructive sleep apnea : a randomized feasibility study
Sunnybrook Health Science Centre0 sites45 target enrollmentStarted: January 9, 2023Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. With OSA (defined as an apnea-hypopnea index =10/h) in whom >50% of the respiratory events are obstructive in nature
- •2. Unwilling to use CPAP or have been unable to tolerate CPAP after at least a 2-week trial
- •3. 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
- •1. Planned airway surgery, use of CPAP, a dental appliance, or other equipment-based treatment modality to manage OSA during the course of the study
- •2. Central respiratory events account for =50% of the overall apnea-hypopnea index
- •3. Reduced cognition (Montreal Cognitive Assessment [MoCA] <18)
- •4. Any significant neurological condition that could impact oropharyngeal activity
- •5. Use of medications that may impact the tone of the upper airway (e.g. hypnotics, opiates) =3 nights per week during the 4 weeks prior to randomization
- •6. Use of a medical device that would interfere with the use of the home sleep apnea test
- •7. Plans to move to another city during the study that would impact compliance. As it would be unethical to withhold CPAP therapy (current first-line therapy for moderate to severe OSA), we will only be recruiting patients who are unwilling to use CPAP therapy or those who are unable to tolerate CPAP after at least a 2-week trial
Investigators
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