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StimAire Sleep Study

NCT05374941 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

DEVICE

Injectable and wearable neurostimulator for the hypoglossal nerve

Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Sponsors & Collaborators

  • StimAire Australia Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Peter Cistulli, Prof. · Sleep & Breathing Specialist Centre

  • Andrew Wignall, Dr. · Denistone 52 ENT

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-04-12
Completion
2023-04-12

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05374941 on ClinicalTrials.gov