Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Recruiting now · Not applicable
Conditions studied: Obstructive Sleep Apnea, Obstructive Sleep Apnea of Adult
In brief
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).
Key facts
- Study ID
- NCT06720545
- Run by
- Columbia University
- People needed
- 60
- Starts
- 2025-01-05
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2025-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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