Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881512
• Other study ID #: SOMN-001
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: February 22, 2023

Study information

• Verified date: May 2023
• Source: Somnial Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 22, 2023
• Est. primary completion date: September 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or female, aged 18 years or older

• In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA

• In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, <25% of the respiratory events on the diagnostic PSG can be attributed to central apneas

• BMI less than or equal to 32

Exclusion Criteria:

• No or mild OSA (AHI <15/h) or very severe OSA (AHI >50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.

• Patients who are cachectic (BMI <18.5 kg/m2) or obese (BMI >32 kg/m2).

• Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.

• Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• OSA
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Transcutaneous Upper Airway Stimulation Device
Multiple frequency stimulation of the hypoglossal nerve

Locations

Country	Name	City	State
United States	United Diagnostics	Commack	New York

Sponsors (1)

Lead Sponsor	Collaborator
Somnial Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep Quality	Subjective Questionnaire	Overnight (day 1)
Primary	Apnea Hypopnea Index	Episodes of apnea and/or hypopnea scored during the course of sleep study	Overnight (day 1)
Secondary	Arterial Oxygen Saturation (SaO2)	SaO2 levels during the course of sleep study compared to baseline	Overnight (day 1)