StimAire Sleep Study

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05374941
• Other study ID #: CIP-SA-001
• Status: Terminated
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: April 2024
• Source: StimAire Australia Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Injectable and wearable neurostimulator for the hypoglossal nerve
Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Locations

Country	Name	City	State
Australia	Sleep & Breathing Specialist Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
StimAire Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of successful placements of device	Number of successful placements of the device	Up to 15 Months
Primary	Change in AHI	Number of apnea or hypopnea events per hour represented by AHI score	Up to 15 Months
Secondary	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