Status:
TERMINATED
StimAire Sleep Study
Lead Sponsor:
StimAire Australia Pty Ltd
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor. The system is to b...
Detailed Description
The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor. The system is to b...
Eligibility Criteria
Inclusion
- Obstructive Sleep Apnea (defined by AHI \> 15 and \< 50 per hour of sleep with non-supine AHI\>10; with hypopneas defined as greater than 30% reduction in airflow with 3% or greater drop in oxygen saturation). AHI will be determined by full night polysomnography 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 the neck and the mandible.
Exclusion
- Body mass index \> 32 kg/m2. Obese individuals are less responsive to OSA neurostimulation.
- 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 \[New York heart Association Category III or IV\]; 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., periodic limb movement arousal index \> 10, insomnia, obesity hypoventilation syndrome, or narcolepsy).
- Hypoglossal nerve palsy on either hypoglossal nerve.
- Prior diagnosis of neuromuscular disease.
- Recent or recurring history of recreational drug use leading to tolerance or dependence, at the discretion of the investigators
- Prior diagnosis of persistent uncontrolled hypertension despite antihypertensive medication 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 may compromise this study results.
- Hypoglossal nerve depth greater than 2.5 cm at the target location of the stimulating electrode as observed on ultrasound display.
- Tonsil size of 3 or 4 (tonsils visible beyond the pillars or extending to midline) or another anatomical obstruction, at the discretion of the investigators
- The participant is not appropriate for the regimen for another reason, at the discretion of the investigators
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05374941
Start Date
August 17 2022
End Date
April 12 2023
Last Update
April 18 2024
Active Locations (1)
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1
Sleep & Breathing Specialist Centre
Sydney, New South Wales, Australia, 2065