Obstructive Sleep ApneaNCT05374941

StimAire Sleep Study

A study testing Injectable and wearable neurostimulator for the hypoglossal nerve in people with Obstructive Sleep Apnea, run by StimAire Australia Pty Ltd at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Injectable and wearable neurostimulator for the hypoglossal nerve
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteAustralia
Study dates: 17 Aug 2022to 12 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 19Show fewer

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
Actively participating in another clinical trial that to the investigators opinion may compromise this study results.
Hypoglossal nerve depth greater than 2.5 cm at the target location of the stimulating electrode as observed on ultrasound display.
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
The participant is not appropriate for the regimen for another reason, at the discretion of the investigators

Trial locations and contacts

1 site in 1 country.

Australia1 site

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

Other trials in Australia

About this study

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

The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.

Read the detailed description

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
Being tested: Injectable and wearable neurostimulator for the hypoglossal nerve
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Injectable and wearable neurostimulator for the hypoglossal nerveDevice
Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve

Study groups in NCT05374941
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Injectable and wearable neurostimulator for the hypoglossal nerve

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in AHI
Number of apnea or hypopnea events per hour represented by AHI score
Measured: 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
Number of apnea or hypopnea events per hour represented by AHI score
Measured: Up to 15 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Aug 202212 Apr 2023

First posted16 May 2022
Study start17 Aug 2022
Primary completion12 Apr 2023
Study completion12 Apr 2023

Why it stopped: Technical issues related to the intervention

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05374941
Sponsor's protocol ID: CIP-SA-001
Status last verified: Apr 2024
First submitted: 24 Mar 2022
Last updated: 18 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Interventional Open Feasibility Sleep Study to Determine Effectiveness of StimAire's Injectable and Wearable Neurostimulator in Participants With Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT05374941
Acronym / sponsor ID: CIP-SA-001
Conditions: Obstructive Sleep Apnea
Study type: Interventional
Recruitment status: TerminatedReason stopped: Technical issues related to the intervention
Enrolment: 7 participants (actual)
Lead sponsor: StimAire Australia Pty LtdIndustry (pharma, biotech, devices)
Study start: 17 Aug 2022 (actual)
Primary completion: 12 Apr 2023 (actual)
Study completion: 12 Apr 2023 (actual)
First posted: 16 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.

Detailed description

The Sponsor will be evaluating the change in Apnea-Hypopnea Index (AHI) when using the StimAire Model S system.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stimulation not synchronized with breathing	Experimental	Device: Injectable and wearable neurostimulator for the hypoglossal nerveParticipants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable without a breathing sensor.
Stimulation during inhalation only	Experimental	Device: Injectable and wearable neurostimulator for the hypoglossal nerveParticipants will be injected with the StimAire Model S Injectable neurostimulator for the hypoglossal nerve, using a wearable with a breathing sensor.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Injectable and wearable neurostimulator for the hypoglossal nerveTemporary placement of injectable and wearable neurostimulator for the hypoglossal nerve	Device	Stimulation during inhalation only, Stimulation not synchronized with breathing

Primary outcome

Change in AHI
Time frame: Up to 15 Months
Number of apnea or hypopnea events per hour represented by AHI score

1 secondary outcome

Change in AHI from baseline for stimulation synchronized with inhalation compared to change in AHI for unsynchronized stimulation
Time frame: Up to 15 Months

Results and safety

The study was stopped early (reason given: Technical issues related to the intervention). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
Individual participant dataSharing planned: Undecided

Related trials for Obstructive Sleep Apnea

Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Cistulli, Prof. principal investigator

Sleep & Breathing Specialist Centre

Andrew Wignall, Dr. principal investigator

Denistone 52 ENT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Injectable and wearable neurostimulator for the hypoglossal nerve in people with Obstructive Sleep Apnea, run by StimAire Australia Pty Ltd at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Technical issues related to the intervention). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AHI (time frame: Up to 15 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.