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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06415981
• Other study ID #: IM-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Invicta Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Hypoglossal nerve and/or Ansa Cervicalis stimulation
Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Invicta Medical Inc.	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of participant adverse events observed during the study	To evaluate and report all observed participant adverse events observed during study.	Day 30