Investigating a new treatment for obstructive sleep apnea using nerve and muscle stimulation
Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea
This study is testing a new treatment for obstructive sleep apnea by using nerve and muscle stimulation to see if it can improve breathing and sleep quality.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Invicta Medical Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Wollongong, New South Wales and 3 other locations) |
| Trial ID | NCT06627127 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility and respiratory effects of stimulating specific neural and muscular targets to treat obstructive sleep apnea (OSA). Participants will undergo a Drug Induced Sleep Endoscopy (DISE) to evaluate changes in airflow with stimulation from electrode arrays placed on the hypoglossal nerve, genioglossus muscle, and other targets. Data will be collected during polysomnography (PSG) to analyze airflow and sleep stability responses with varying levels of stimulation. The study will also measure OSA severity through the apnea/hypopnea index (AHI) to compare stimulation effects.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a body mass index under 35 and documented moderate to severe obstructive sleep apnea.
Not a fit: Patients with major anatomical or functional abnormalities that impair treatment effectiveness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from obstructive sleep apnea.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using nerve stimulation for sleep apnea treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study: * Age above 18 years not under guardianship, under curatorship or under judicial protection. * Body Mass Index (BMI) \< 35 kg/m2. * OSA (15 \< AHI \< 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues. * Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only). * Written informed consent obtained from the subject prior to performing any study specific procedure. * Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial. Exclusion Criteria: Subjects meeting any of the following criteria will be excluded from participation in this study: * Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned. * Significant comorbidities that contraindicate surgery or general anesthesia/DISE * Significant tongue weakness * Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator. * Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems: * Airway cancer surgery or radiation, * Mandible or maxilla surgery in the previous 3 years (not counting dental treatments), * Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery), * Prior hypoglossal nerve stimulation device implantation. * Currently pregnant, or breastfeeding during the study period
Where this trial is running
Wollongong, New South Wales and 3 other locations
- Illawara ENT — Wollongong, New South Wales, Australia (Recruiting)
- Complete ENT — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Adelaide Institute for Sleep Health, Flinders University — Adelaide, South Australia, Australia (Recruiting)
- Perth Head and Neck Surgery — Perth, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Tim Fayram, MS
- Email: tfayram@invictamedical.com
- Phone: +1 4086127570
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.