Evaluating the effects of hypoglossal nerve stimulation on metabolism in sleep apnea patients
Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA
This study is testing if a therapy that stimulates a nerve in the tongue can help people with sleep apnea improve their metabolism and reduce health risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06720545 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older who have been using HGNS therapy effectively for at least three months.
Not a fit: Patients with chronic opiate use, pregnancy, or severe excessive daytime sleepiness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved metabolic health and reduced medical risks for patients with obstructive sleep apnea.
How similar studies have performed: While hypoglossal nerve stimulation has been studied, this specific focus on metabolic outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.