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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06415981

Enrollment

Registered

2024-05-16

Start date

2022-12-21

Completion date

2024-07-31

Last updated

2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sleep Apnea

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.

Interventions

DEVICEHypoglossal nerve and/or Ansa Cervicalis stimulation

Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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).

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026