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

Invicta Medical

Status: Enrolling

Conditions: Sleep Apnea Syndromes; Sleep Disorder; Sleep Apnea, Obstructive; Sleep Apnea

Treatments: Device: Target stimulation (HGN, AC, GG, Strap muscles)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06627127

IM-005

Details and patient eligibility

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Target stimulation

Experimental group

Description:

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:

Device: Target stimulation (HGN, AC, GG, Strap muscles)