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

NCT ID: NCT06415981

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2024-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Hypoglossal nerve and/or Ansa Cervicalis stimulation

Group Type: EXPERIMENTAL

Hypoglossal nerve and/or Ansa Cervicalis stimulation

Intervention Type: DEVICE

Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

Interventions

Hypoglossal nerve and/or Ansa Cervicalis stimulation

Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College London Hospitals

OTHER

Sponsor Role: collaborator

Invicta Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University College London Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

IM-003

Identifier Type: -

Identifier Source: org_study_id