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Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

This study is looking at how temporarily stopping hypoglossal nerve stimulation (HGNS) therapy affects your heart health and metabolism. HGNS is an implanted device used to treat obstructive sleep apnea (OSA). Researchers want to see if turning off your HGNS for 2-4 weeks changes your risk for medical problems linked to OSA. You may be able to join if you are an adult, speak English, have been using HGNS successfully for at least 3 months, and use it for more than 20 hours a week. The study will measure your energy use and how much your oxygen levels drop during sleep to understand these effects. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 60 participants. It involves a period where participants will have their HGNS therapy turned off.
What's involved
You would have your HGNS therapy turned off for 2-4 weeks. Data on your energy expenditure and hypoxic burden will be collected during the last two weeks of both your HGNS-on and HGNS-off phases.
Compensation
Not stated in the trial record.
Follow-up
Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06720545

Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Recruiting
NAAges 18+InterventionalTreatment
Columbia University
~60 participants
Updated 2025-07-10 on ClinicalTrials.gov
What's tested:No HGNS therapy (HGNS-off)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Free living energy expenditure
Measured over Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
+1 more outcome measured

Conditions

Obstructive Sleep Apnea
Obstructive Sleep Apnea of Adult

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
New York1

Who to contact

Otolaryngology Research Group
[email protected]
646-317-3252
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Free living energy expenditureData will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)

    The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.

  • Hypoxic burdenData will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).

    The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.