StimAire Sleep Study

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

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 be used in participants diagnosed with moderate to severe Obstructive Sleep Apnea.

The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.
  2. Age range > 18 years.
  3. Difficulty accepting or adhering to, or not desiring of, CPAP therapy.
  4. Participant has willingly consented to participate in the study.
  5. Participant is willing to remove or have removed facial hair between the base of theneck and the mandible.

Exclusion

Exclusion Criteria:

  1. Body mass index > 32 kg/m2. Obese individuals are less responsive to OSAneurostimulation.
  2. Documented central or complex sleep apnea > 5 per hour.
  3. Participants with pacemaker, defibrillator, or implanted neurostimulators.
  4. Hypoxemic and requiring oxygen supplementation.
  5. Prior diagnosis of Decompensated cardiac (heart failure [New York heart AssociationCategory III or IV]; or angina) or pulmonary (severe COPD or uncontrolled asthma)disease.
  6. Prior diagnosis of any moderate to severe pulmonary artery hypertension.
  7. Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodiclimb movement arousal index > 10, insomnia, obesity hypoventilation syndrome, ornarcolepsy).
  8. Hypoglossal nerve palsy on either hypoglossal nerve.
  9. Prior diagnosis of neuromuscular disease.
  10. Recent or recurring history of recreational drug use leading to tolerance ordependence, at the discretion of the investigators
  11. Prior diagnosis of persistent uncontrolled hypertension despite antihypertensivemedication use.
  12. Any unstable medical or psychiatric comorbidity at the discretion of the investigators
  13. Actively taking anticoagulation medication
  14. Aspirin taken within 2 weeks prior to injection at the discretion of the investigators
  15. Bilateral or unilateral pathology in the submandibular space
  16. Actively participating in another clinical trial that to the investigators opinion maycompromise this study results.
  17. Hypoglossal nerve depth greater than 2.5 cm at the target location of the stimulatingelectrode as observed on ultrasound display.
  18. Tonsil size of 3 or 4 (tonsils visible beyond the pillars or extending to midline) oranother anatomical obstruction, at the discretion of the investigators
  19. 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

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 be used in participants diagnosed with moderate to severe Obstructive Sleep Apnea.

The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.

Single-site controlled AHI measurements both baseline and intervention will be obtained in this open labeled feasibility study. A baseline AHI measurement will be established for each participant, followed by an intervention AHI measurement.

Connect with a study center

  • Sleep & Breathing Specialist Centre

    Sydney, New South Wales 2065
    Australia

    Site Not Available

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