StimAire Sleep Study

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Injectable and wearable neurostimulator for the hypoglossal nerve

• Registration Number: NCT05374941
• Lead Sponsor: StimAire Australia Pty Ltd

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 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.

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 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.

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Study Start: 2022-08-17
• Primary Completion: 2023-04-12
• Study Completion: 2023-04-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. 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.
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 the neck and the mandible.

Exclusion Criteria

1. Body mass index > 32 kg/m2. Obese individuals are less responsive to OSA neurostimulation.
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 Association Category 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., periodic limb movement arousal index > 10, insomnia, obesity hypoventilation syndrome, or narcolepsy).
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 or dependence, at the discretion of the investigators
11. Prior diagnosis of persistent uncontrolled hypertension despite antihypertensive medication 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 may compromise this study results.
17. Hypoglossal nerve depth greater than 2.5 cm at the target location of the stimulating electrode as observed on ultrasound display.
18. 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
19. The participant is not appropriate for the regimen for another reason, at the discretion of the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation during inhalation only	Injectable and wearable neurostimulator for the hypoglossal nerve	Participants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable with a breathing sensor.
Stimulation not synchronized with breathing	Injectable and wearable neurostimulator for the hypoglossal nerve	Participants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable without a breathing sensor.

Primary Outcome Measures

Name	Time	Method
Change in AHI	Up to 15 Months	Number of apnea or hypopnea events per hour represented by AHI score

Secondary Outcome Measures

Name	Time	Method
Change in AHI from baseline for stimulation synchronized with inhalation compared to change in AHI for unsynchronized stimulation	Up to 15 Months	Number of apnea or hypopnea events per hour represented by AHI score

Trial Locations

Locations (1)

Sleep & Breathing Specialist Centre; 🇦🇺 Sydney, New South Wales, Australia