Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea

NCT06415981 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IM-003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.

Conditions

Sleep Apnea; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes

Keywords

Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Incidence of participants with changes in cross-sectional area airway opening during target stimulation

  Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.

  Day 0

• Assessment of changes in airflow outcomes

  Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).

  Day 0

Secondary Outcomes (1)

• Number of participant adverse events observed during the study

  Day 30

Study Arms (1)

Hypoglossal nerve and/or Ansa Cervicalis stimulation

EXPERIMENTAL

Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

Interventions

Hypoglossal nerve and/or Ansa Cervicalis stimulation DEVICE

Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

Hypoglossal nerve and/or Ansa Cervicalis stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years not under guardianship, under curatorship or under judicial protection.
• Body Mass Index (BMI) \< 35 kg/m2.
• Subject suffers from OSA (15 \< AHI \< 80) documented by a sleep study performed during the past 36 months.
• Subject must be eligible for a diagnostic or surgical procedure.
• 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.

You may not qualify if:

• 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
• 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,
• 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

Sponsors & Collaborators

• Invicta Medical Inc.: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospital

London, NWI 2PG, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: December 21, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)