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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/NCT06283017




Registration number
NCT06283017
Ethics application status
Date submitted
13/02/2024
Date registered
28/02/2024
Date last updated
13/03/2024

Titles & IDs
Public title
Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Scientific title
Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Secondary ID [1] 0 0
IM-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Sleep Apnea, Obstructive 0 0
Sleep Disorder 0 0
Sleep Apnea Syndromes 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hypoglossal nerve stimulation

Experimental: Hypoglossal nerve stimulation - Device-mediated stimulation of the hypoglossal nerve


Treatment: Devices: Hypoglossal nerve stimulation
Device stimulation of the hypoglossal nerve
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target identification and access outcomes
Timepoint [1] 0 0
Day 0
Primary outcome [2] 0 0
Tongue protrusion outcomes
Timepoint [2] 0 0
Day 0
Primary outcome [3] 0 0
Characterization of lead placement outcomes
Timepoint [3] 0 0
Day 0
Primary outcome [4] 0 0
Lead placement and removal outcomes
Timepoint [4] 0 0
Day 0
Primary outcome [5] 0 0
Safety outcomes
Timepoint [5] 0 0
Day 30

Eligibility
Key inclusion criteria
Subject must be eligible for a diagnostic or surgical procedure and

- Suffers from OSA (apnea/hypopnea index >10 event/h sleep) based on history and a
physical exam.

- Is a surgical candidate.

- Is willing and capable of providing informed consent.

- Is willing to have a representative electrode array temporarily placed in the
submandibular and mylohyoid space.

- Is willing to participate in the designated follow-up visits.

- Must be in good general health.

- Is able to understand and has voluntarily signed and dated the IRB or EC approved
informed consent form (ICF) prior to initiation of any screening or study-specific
procedure.

- Must be minimum of 18 years and maximum 80 years of age.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has Body Mass Index above 35 kg/m2.

- Has had surgical resection or radiation therapy for cancer or congenital malformations
in the larynx, tongue, or throat.

- Has significant co-morbidities making them unable or inappropriate to participate in
this POC study.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Adelaide Institute for Sleep Health, Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Invicta Medical Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Adelaide Institute for Sleep Health, Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can
be stimulated using a small series of electrodes placed surgically via a percutaneous
approach. Minimally invasive off the shelf medical devices will be used and observation of
the characteristic physiological responses to stimulation of the HGN, will be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06283017
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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