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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)

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Conditions

Obstructive Sleep ApneaObstructive Sleep Apnea of Adult

Locations

Columbia University Medical Center

New York, New York 10032

United States