StimAire Sleep Study

An Interventional Open Feasibility Sleep Study to Determine Effectiveness of StimAire's Injectable and Wearable Neurostimulator in Participants With Obstructive Sleep Apnea

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Injectable and wearable neurostimulator for the hypoglossal nerve

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nik Kosov; Phone Number: +61289370952; Email: Nik.m.kosov@hotmail.com
• Study Contact Backup: Name: Charles Aznavoorian; Phone Number: +61294606688; Email: Charles.Aznavoorian@avaniaclinical.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2065
      • Sleep & Breathing Specialist Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Injectable and wearable neurostimulator for the hypoglossal nerve; Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve
Experimental: 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.	Device: Injectable and wearable neurostimulator for the hypoglossal nerve; Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in AHI	Number of apnea or hypopnea events per hour represented by AHI score	Up to 15 Months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of successful placements of device	Number of successful placements of the device	Up to 15 Months

Collaborators and Investigators

• Sponsor: StimAire Australia Pty Ltd
• Investigators: Principal Investigator: Peter Cistulli, Prof., Sleep & Breathing Specialist Centre; Principal Investigator: Andrew Wignall, Dr., Denistone 52 ENT

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): April 12, 2023
• Study Completion (Actual): April 12, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIP-SA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No