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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea
• Intervention / Treatment: Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NWI 2PG
    • University College London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypoglossal nerve and/or Ansa Cervicalis stimulation	Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation; Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant adverse events observed during the study	To evaluate and report all observed participant adverse events observed during study.	Day 30

Collaborators and Investigators

• Sponsor: Invicta Medical Inc.
• Collaborators: University College London Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Sleep Apnea
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Apnea
• Other Study ID Numbers: IM-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes