Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
• Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.
Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Katie Hartley-Estes, RPSGT
katherine.e.hartley@vumc.org
615-875-9214
Backup
Nicole L Jones, MS
nicole.l.jones@vumc.org
615-936-2807
Time Frame
Start Date: 2022-11-03
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 100
Treatments
Experimental: Muscle stimulation
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and second sleep study and the Grass S88 (or comparable) muscle stimulator.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center