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Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Obstructive Sleep Apnea
    Obstructive Sleep Apnea of Adult

NCT06720545

Columbia University

16 October 2025

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