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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06635265




Registration number
NCT06635265
Ethics application status
Date submitted
2/10/2024
Date registered
10/10/2024

Titles & IDs
Public title
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Scientific title
Single Center Proof-of-Concept Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
Secondary ID [1] 0 0
IM_004
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 a combination of targets: Hypoglossal nerve (HGN) and Ansa Cervicalis (AC), Genioglossus (GG) and AC, HGN and strap muscles, or GG and strap muscles, during an acute and sub-acute phase.


Treatment: Devices: Target Stimulation (HGN, AC, GG, Strap muscles)
Simulation of a combination of: HGN, AC, GG or strap muscles
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Impacts on acute airway opening
Timepoint [1] 0 0
Day 0 to 3
Primary outcome [2] 0 0
Impacts on airflow during a acute assessment
Timepoint [2] 0 0
Day 0 to 3
Secondary outcome [1] 0 0
Impacts on airway opening during a sub-acute assessment
Timepoint [1] 0 0
Day 0 to 3

Eligibility
Key inclusion criteria
A patient 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) < 38 kg/m2.
* Subject must be eligible for neck dissection surgery.
* Written informed consent obtained from the patient 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
Patients 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.
* Significant tongue weakness.
* Aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection.
* Any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia 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, or
* 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.
* Concomitant oral or pharyngeal surgery.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2024
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Perth Head and Neck Surgery - Perth
Recruitment postcode(s) [1] 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
Hollywood Private Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06635265