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

Not Applicable

Active, not recruiting

• Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes
• Interventions: Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

• Registration Number: NCT06415981
• Lead Sponsor: Invicta Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-21
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypoglossal nerve and/or Ansa Cervicalis stimulation	Hypoglossal nerve and/or Ansa Cervicalis stimulation	-

Primary Outcome Measures

Name	Time	Method
Assessment of changes in airflow outcomes	Day 0	Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).
Incidence of participants with changes in cross-sectional area airway opening during target stimulation	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Number of participant adverse events observed during the study	Day 30	To evaluate and report all observed participant adverse events observed during study.

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom