Evaluating the effects of hypoglossal nerve stimulation on metabolism in sleep apnea patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of hypoglossal nerve stimulation (HGNS) therapy on metabolic outcomes and inflammation in patients with obstructive sleep apnea (OSA). Participants will have been using HGNS for at least three months and will undergo assessments to determine if the therapy reduces their risk of medical complications associated with OSA. The study aims to provide insights into how HGNS may influence metabolic health in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Otolaryngology Research Group
• Email: otosleepresearch@cumc.columbia.edu
• Phone: 646-317-3252

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.