StimAire Sleep Study

NCT ID: NCT05374941

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2023-04-12

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Stimulation not synchronized with breathing

Participants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable without a breathing sensor.

Group Type: EXPERIMENTAL

Injectable and wearable neurostimulator for the hypoglossal nerve

Intervention Type: DEVICE

Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Stimulation during inhalation only

Participants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable with a breathing sensor.

Group Type: EXPERIMENTAL

Injectable and wearable neurostimulator for the hypoglossal nerve

Intervention Type: DEVICE

Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Interventions

Injectable and wearable neurostimulator for the hypoglossal nerve

Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

StimAire Australia Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Peter Cistulli

Director, Affiliation is Sleep and Breathing Specialist Centre, Sydney

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Cistulli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sleep & Breathing Specialist Centre

Andrew Wignall, Dr.

Role: PRINCIPAL_INVESTIGATOR

Denistone 52 ENT

Locations

Sleep & Breathing Specialist Centre

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

CIP-SA-001

Identifier Type: -

Identifier Source: org_study_id