Last updated: April 16, 2024
Sponsor: StimAire Australia Pty Ltd
Overall Status: Terminated
Phase
N/A
Condition
Sleep Apnea Syndromes
Treatment
Injectable and wearable neurostimulator for the hypoglossal nerve
Clinical Study ID
NCT05374941
CIP-SA-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Obstructive Sleep Apnea (defined by AHI > 15 and < 50 per hour of sleep withnon-supine AHI>10; with hypopneas defined as greater than 30% reduction in airflowwith 3% or greater drop in oxygen saturation). AHI will be determined by full nightpolysomnography as per guidelines of the American Academy of Sleep Medicine.
- Age range > 18 years.
- Difficulty accepting or adhering to, or not desiring of, CPAP therapy.
- Participant has willingly consented to participate in the study.
- Participant is willing to remove or have removed facial hair between the base of theneck and the mandible.
Exclusion
Exclusion Criteria:
- Body mass index > 32 kg/m2. Obese individuals are less responsive to OSAneurostimulation.
- Documented central or complex sleep apnea > 5 per hour.
- Participants with pacemaker, defibrillator, or implanted neurostimulators.
- Hypoxemic and requiring oxygen supplementation.
- Prior diagnosis of Decompensated cardiac (heart failure [New York heart AssociationCategory III or IV]; or angina) or pulmonary (severe COPD or uncontrolled asthma)disease.
- Prior diagnosis of any moderate to severe pulmonary artery hypertension.
- Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodiclimb movement arousal index > 10, insomnia, obesity hypoventilation syndrome, ornarcolepsy).
- Hypoglossal nerve palsy on either hypoglossal nerve.
- Prior diagnosis of neuromuscular disease.
- Recent or recurring history of recreational drug use leading to tolerance ordependence, at the discretion of the investigators
- Prior diagnosis of persistent uncontrolled hypertension despite antihypertensivemedication use.
- Any unstable medical or psychiatric comorbidity at the discretion of the investigators
- Actively taking anticoagulation medication
- Aspirin taken within 2 weeks prior to injection at the discretion of the investigators
- Bilateral or unilateral pathology in the submandibular space
- Actively participating in another clinical trial that to the investigators opinion maycompromise this study results.
- Hypoglossal nerve depth greater than 2.5 cm at the target location of the stimulatingelectrode as observed on ultrasound display.
- Tonsil size of 3 or 4 (tonsils visible beyond the pillars or extending to midline) oranother anatomical obstruction, at the discretion of the investigators
- The participant is not appropriate for the regimen for another reason, at thediscretion of the investigators
Study Design
Total Participants: 7
Treatment Group(s): 1
Primary Treatment: Injectable and wearable neurostimulator for the hypoglossal nerve
Phase:
Study Start date:
August 17, 2022
Estimated Completion Date:
April 12, 2023
Study Description
Connect with a study center
Sleep & Breathing Specialist Centre
Sydney, New South Wales 2065
AustraliaSite Not Available
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