Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Launched by COLUMBIA UNIVERSITY · Dec 2, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a treatment called hypoglossal nerve stimulation (HGNS) can help reduce the health risks associated with obstructive sleep apnea (OSA). OSA is a condition where a person’s breathing is repeatedly interrupted during sleep, which can lead to other health problems. The study aims to see if using HGNS, an implantable device that stimulates the nerve to help keep the airway open, can improve metabolism and reduce inflammation in patients who have been using this therapy for at least three months.

To participate in the trial, you must be an English-speaking adult over 18 who has experienced significant improvement in your apnea symptoms with HGNS, specifically showing at least a 50% reduction in breathing interruptions. Participants should have been using the device regularly, for more than 20 hours a week, and should not have used other OSA treatments for at least a month before starting HGNS. Throughout the study, participants will be monitored for changes in their health and wellbeing. It’s important to note that certain individuals, such as those with severe sleepiness, significant health issues, or those who are pregnant, may not be eligible to join the trial.

Gender

ALL

Eligibility 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