StimAire Sleep Study

NCT05374941 | Terminated

• 1 other identifier: CIP-SA-001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in AHI

  Number of apnea or hypopnea events per hour represented by AHI score

  Up to 15 Months

Secondary Outcomes (1)

• Change in AHI from baseline for stimulation synchronized with inhalation compared to change in AHI for unsynchronized stimulation

  Up to 15 Months

Other Outcomes (1)

• Percent of successful placements of device

  Up to 15 Months

Study Arms (2)

Stimulation not synchronized with breathing

EXPERIMENTAL

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

Stimulation during inhalation only

EXPERIMENTAL

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

Interventions

Injectable and wearable neurostimulator for the hypoglossal nerve DEVICE

Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Stimulation during inhalation only; Stimulation not synchronized with breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Body mass index \> 32 kg/m2. Obese individuals are less responsive to OSA neurostimulation.
• Documented central or complex sleep apnea \> 5 per hour.
• Participants with pacemaker, defibrillator, or implanted neurostimulators.
• Hypoxemic and requiring oxygen supplementation.
• 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.
• Prior diagnosis of any moderate to severe pulmonary artery hypertension.
• 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).
• Hypoglossal nerve palsy on either hypoglossal nerve.
• Prior diagnosis of neuromuscular disease.
• Recent or recurring history of recreational drug use leading to tolerance or dependence, at the discretion of the investigators
• Prior diagnosis of persistent uncontrolled hypertension despite antihypertensive medication use.
• Any unstable medical or psychiatric comorbidity at the discretion of the investigators
• Actively taking anticoagulation medication
• Aspirin taken within 2 weeks prior to injection at the discretion of the investigators
• Bilateral or unilateral pathology in the submandibular space

Sponsors & Collaborators

• StimAire Australia Pty Ltd: lead

Study Sites (1)

Sleep & Breathing Specialist Centre

Sydney, New South Wales, 2065, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Injections

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Peter Cistulli, Prof.

  Sleep & Breathing Specialist Centre

  PRINCIPAL INVESTIGATOR

• Andrew Wignall, Dr.

  Denistone 52 ENT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Affiliation is Sleep and Breathing Specialist Centre, Sydney

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: May 16, 2022
• Study Start: August 17, 2022
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

AU (1)