Actively Recruiting
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
Led by Invicta Medical Inc. · Updated on 2024-10-04
35
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Invicta Medical Inc.
Lead Sponsor
A
Adelaide Institute for Sleep Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age above 18 years and not under guardianship, curatorship, or judicial protection
- Body Mass Index (BMI) less than 35 kg/m2
- Obstructive sleep apnea with apnea/hypopnea index (AHI) between 15 and 80 events per hour documented by a sleep study within the past 24 months without major weight change or medical issues
- Eligible for a diagnostic Drug Induced Sleep Endoscopy (DISE) or surgical procedure (for acute study measures only)
- Provided written informed consent before any study-specific procedures
- Willing and able to comply with all study requirements, including lifestyle considerations, evaluations, and questionnaires throughout the trial
You will not qualify if you...
- Major anatomical or functional abnormalities preventing electrode array placement
- Significant health conditions that contraindicate surgery or general anesthesia/DISE
- Significant tongue weakness
- Any chronic medical illness or condition that contraindicates surgery or general anesthesia/DISE as judged by the investigator
- Prior airway cancer surgery or radiation
- Mandible or maxilla surgery in the last 3 years (excluding dental treatments)
- Upper airway surgery related to obstructive sleep apnea in the past 3 months (e.g., uvulopalatopharyngoplasty, tonsillectomy, nasal airway surgery)
- Previous hypoglossal nerve stimulation device implantation
- Currently pregnant or breastfeeding during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Illawara ENT
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Complete ENT
Brisbane, Queensland, Australia, 4000
Not Yet Recruiting
3
Adelaide Institute for Sleep Health, Flinders University
Adelaide, South Australia, Australia, 5042
Actively Recruiting
4
Perth Head and Neck Surgery
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
T
Tim Fayram, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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