Clinical trial NCT06627127: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorder
Keywords: Sleep Apnea device
Lead sponsor: Invicta Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Adelaide Institute for Sleep Health
name: The University of Western Australia
name: Flinders University
First posted: 2024-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, proof- of-concept (POC) study. Electrode arrays percutaneously placed under ultrasound adjacent to nerves, connected to an external pulse generator will be used to evaluate the combined effect of short-term stimulation on airflow and/or AHI.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

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

Primary outcomes:
measure: Feasibility of technical delivery in stimulating target nerves or muscles
timeFrame: Day 0 to 3
measure: Assessment of the required stimulation amplitude
timeFrame: Day 0 to 3
measure: Feasibility of participant recruitment and retention
timeFrame: Day 0 to 30
Secondary outcomes:
measure: Acute increase in airflow measured during target stimulation
timeFrame: Day 0 to 3
measure: Assessment of acute airway opening during target stimulation
timeFrame: Day 0 to 3
measure: Assessment of sub-acute airflow increase and/or AHI reduction during target stimulation during a sleep study.
timeFrame: Day 0 to 3
Other outcomes:
Locations:
city: Wollongong
country: Australia
facility: Illawara ENT
state: New South Wales
city: Brisbane
country: Australia
facility: Complete ENT
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Institute for Sleep Health, Flinders University
state: South Australia
city: Perth
country: Australia
facility: Perth Head and Neck Surgery
state: Western Australia
Study officials:
References: