NCT06720545NARecruiting
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Columbia University
Start Date
1/5/2025
Completion Date
1/1/2028
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DEVICE
No HGNS therapy (HGNS-off)
Conditions
Obstructive Sleep ApneaObstructive Sleep Apnea of Adult
Locations
Columbia University Medical Center
New York, New York 10032
United States