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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05374941




Registration number
NCT05374941
Ethics application status
Date submitted
24/03/2022
Date registered
16/05/2022
Date last updated
18/04/2024

Titles & IDs
Public title
StimAire Sleep Study
Scientific title
An Interventional Open Feasibility Sleep Study to Determine Effectiveness of StimAire's Injectable and Wearable Neurostimulator in Participants With Obstructive Sleep Apnea
Secondary ID [1] 0 0
CIP-SA-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Injectable and wearable neurostimulator for the hypoglossal nerve

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.

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.


Treatment: Devices: Injectable and wearable neurostimulator for the hypoglossal nerve
Temporary placement of injectable and wearable neurostimulator for the hypoglossal nerve
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in AHI
Timepoint [1] 0 0
Up to 15 Months
Secondary outcome [1] 0 0
Change in AHI from baseline for stimulation synchronized with inhalation compared to change in AHI for unsynchronized stimulation
Timepoint [1] 0 0
Up to 15 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2023
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sleep & Breathing Specialist Centre - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
StimAire Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05374941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Cistulli, Prof.
Address 0 0
Sleep & Breathing Specialist Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05374941