Home › Obstructive Sleep Apnea › NCT06720545
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Recruiting
Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, as defined by at least a 50% reduction in apnea-hypopnea index (AHI) to \<20 (with hypopneas defined by 4% oxyhemoglobin desaturations) * Have been using HGNS therapy for at least 3 months and used HGNS for \>20 hours/week during the past 4 weeks * Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation Exclusion Criteria: * Chronic use of opiate medications, illicit drugs, or alcohol dependency * Women who are pregnant or planning to become pregnant * Shift workers, heavy machinery operators, or commercial drivers * History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score \>16 at time of screening or prior to HGNS), motor vehicle accidents or near-miss incidents due to drowsy driving within the year prior to enrollment * Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years) * Inability to provide informed consent
About the study
Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea.
The study will evaluate the effect of this treatment on cardiovascular and metabolism-related measures to see if it affects patients' risk of medical problems associated with obstructive sleep apnea (OSA).
What is being tested
- No HGNS therapy (HGNS-off) (device)
Sponsor: Columbia University · Participants: 60 · Started: Jan 5, 2025
Contact the study team
- Otolaryngology Research Group · Phone: 646-317-3252
Official record on ClinicalTrials.gov — NCT06720545
Locations in the U.S.
| New York | Columbia University Medical Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.