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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06627127




Registration number
NCT06627127
Ethics application status
Date submitted
24/06/2024
Date registered
4/10/2024
Date last updated
4/10/2024

Titles & IDs
Public title
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea
Scientific title
Multicenter Proof-of-Concept Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea
Secondary ID [1] 0 0
IM-005
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 Apnea Syndromes 0 0
Sleep Disorder 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 - Target stimulation (HGN, AC, GG, Strap muscles)

Experimental: Target stimulation - Stimulation of the Hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid).


Treatment: Devices: Target stimulation (HGN, AC, GG, Strap muscles)
Stimulation of the HGN or GG along with AC or strap muscles.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of technical delivery in stimulating target nerves or muscles
Timepoint [1] 0 0
Day 0 to 3
Primary outcome [2] 0 0
Assessment of the required stimulation amplitude
Timepoint [2] 0 0
Day 0 to 3
Primary outcome [3] 0 0
Feasibility of participant recruitment and retention
Timepoint [3] 0 0
Day 0 to 30
Secondary outcome [1] 0 0
Acute increase in airflow measured during target stimulation
Timepoint [1] 0 0
Day 0 to 3
Secondary outcome [2] 0 0
Assessment of acute airway opening during target stimulation
Timepoint [2] 0 0
Day 0 to 3
Secondary outcome [3] 0 0
Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.
Timepoint [3] 0 0
Day 0 to 3

Eligibility
Key inclusion criteria
A subject must meet all of the following inclusion criteria to be eligible for inclusion in this study:

* Age above 18 years not under guardianship, under curatorship or under judicial protection.
* Body Mass Index (BMI) < 35 kg/m2.
* OSA (15 < AHI < 80 events/h sleep) documented by a sleep study performed during the past 24 months in the absence of any major weight change or other medical issues.
* Subject must be eligible for a diagnostic DISE or surgical procedure (acute study measures only).
* Written informed consent obtained from the subject prior to performing any study specific procedure.
* Willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects meeting any of the following criteria will be excluded from participation in this study:

* Major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned.
* Significant comorbidities that contraindicate surgery or general anesthesia/DISE
* Significant tongue weakness
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia/DISE in the judgment of the investigator.
* Prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems:

* Airway cancer surgery or radiation,
* Mandible or maxilla surgery in the previous 3 years (not counting dental treatments),
* Other upper airway surgery to remove obstructions related to OSA in the previous 3 months (e.g., uvulopalatopharyngoplasty (UPPP), tonsillectomy, nasal airway surgery),
* Prior hypoglossal nerve stimulation device implantation.
* Currently pregnant, or breastfeeding during the study period

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Illawara ENT - Wollongong
Recruitment hospital [2] 0 0
Complete ENT - Brisbane
Recruitment hospital [3] 0 0
Adelaide Institute for Sleep Health, Flinders University - Adelaide
Recruitment hospital [4] 0 0
Perth Head and Neck Surgery - Perth
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4000 - Brisbane
Recruitment postcode(s) [3] 0 0
5042 - Adelaide
Recruitment postcode(s) [4] 0 0
6009 - Perth

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
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The University of Western Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Flinders University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.
Trial website
https://clinicaltrials.gov/study/NCT06627127
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
Tim Fayram, MS
Address 0 0
Country 0 0
Phone 0 0
+1 4086127570
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06627127