Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
NCT ID: NCT05881512
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2022-09-12
2023-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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TUAS
Transcutaneous upper airway stimulation
Transcutaneous Upper Airway Stimulation Device
Multiple frequency stimulation of the hypoglossal nerve
Interventions
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Transcutaneous Upper Airway Stimulation Device
Multiple frequency stimulation of the hypoglossal nerve
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Somnial Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Lee Shangold, MD
Role: PRINCIPAL_INVESTIGATOR
ENT & Allergy Associates, LLP
Locations
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United Diagnostics
Commack, New York, United States
Countries
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Other Identifiers
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SOMN-001
Identifier Type: -
Identifier Source: org_study_id
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