Exploring a new treatment for sleep apnea using airway muscle activation
Exploration of Potential Airway Muscle Activation on Sleep-Disordered Breathing Events Using Air Pressure Maneuvers
This study is testing a new way to treat sleep apnea by using a device that helps activate a muscle in the throat to see if it works better than regular breathing machines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | NovaResp Technologies Inc Industry-sponsored |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06002061 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel approach to treating obstructive sleep apnea (OSA) by stimulating the genioglossus muscle, which is crucial for maintaining airway patency. Participants will undergo an overnight study at a sleep clinic where their personal positive airway pressure (PAP) settings will be integrated with a specialized device that applies brief pressure maneuvers. The study will utilize standard polysomnography (PSG) to monitor genioglossal activity during the intervention. The aim is to assess the effectiveness of this method in reducing sleep-disordered breathing events compared to conventional PAP therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 diagnosed with moderate to severe obstructive sleep apnea and a BMI under 35 kg/m2.
Not a fit: Patients with severe cardiovascular or neurological issues, or those using bi-level PAP or requiring oxygen therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and comfortable alternative for patients suffering from sleep apnea.
How similar studies have performed: While the approach of stimulating the genioglossus muscle is promising, it is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * No history of self-reported, uncontrolled, severe cardiovascular or neurological issues * Must be diagnosed with OSA * Must be between 18 and 70 years old. People over 70 are excluded from this study, as they are more likely to have co-morbidities that overlap with the exclusion criteria for the study. * Must be able to comply with all study requirements as outlined in the consent form * Must be able to understand English and be willing to provide written informed consent * Must be willing to lend their personal PAP device for inspection so that their personal PAP therapy settings can be transferred to one of our CPAP devices that has been modified to include the NovaResp MAPR System. Their device will not be used or modified during the study. * Moderate or worse OSA (baseline AHI \> 15 events/hour) * BMI \< 35 kg/m2 Exclusion Criteria: * Subjects actively using bi-level PAP or require oxygen therapy * History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months. * Subjects who are medically complicated or who are medically unstable (i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness) * Potential sleep apnea complications that in the opinion of the clinician may affect the health and safety of the participant * Inability or unwillingness of individual to give written informed consent * Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment. * A body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of more than 35. * Pregnancy or planning attempting to become pregnant. * Breastfeeding
Where this trial is running
Halifax, Nova Scotia
- Sleep Disorders Clinic — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Study coordinator: Hamed Hanafi, PhD
- Email: hanafi@novaresp.com
- Phone: (902) 403-2443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.