Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if treating obstructive sleep apnea—a condition where breathing stops and starts during sleep—with hypoglossal nerve stimulation (a device that helps keep the airway open) can alter glucose processing and impact heart health. The trial targets individuals who are overweight or obese, have been diagnosed with sleep apnea, and struggle to use other treatments like CPAP machines regularly. This study may suit those seeking alternatives to existing treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to explore new treatment options.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic steroids, you may not be eligible to participate.
What prior data suggests that hypoglossal nerve stimulation is safe for treating obstructive sleep apnea?
Research has shown that hypoglossal nerve stimulation (HNS) is generally safe for treating obstructive sleep apnea (OSA). Most side effects occur during the device's implantation, but these are rare and usually not serious.
HNS achieves high patient satisfaction, and people tend to continue with the treatment. Users report better sleep quality. Overall, the safety profile of HNS is positive, making it a promising option for people with OSA.12345Why are researchers excited about this trial?
Unlike the standard treatments for obstructive sleep apnea, which often involve continuous positive airway pressure (CPAP) machines or mandibular advancement devices, Hypoglossal Nerve Stimulation (HGNS) therapy offers a unique approach. HGNS therapy works by stimulating the twelfth cranial nerve, which controls tongue movements, to prevent airway blockage during sleep. This method is less intrusive than traditional options and can lead to improved comfort and compliance for patients. Researchers are excited about HGNS because it directly targets the neurological control of the tongue, potentially offering a more natural and sustainable solution for reducing sleep apnea symptoms.
What evidence suggests that hypoglossal nerve stimulation is effective for obstructive sleep apnea?
Studies have shown that stimulating the hypoglossal nerve (HGNS) effectively treats obstructive sleep apnea (OSA). Participants in this trial will receive this treatment, which significantly reduces the number of breathing interruptions during sleep by over 20 points. Patients have reported better sleep quality and overall health after using HGNS. Although heart-related outcomes, such as blood pressure, did not change significantly, HGNS still shows promise for improving sleep-related issues. These findings suggest that HGNS can be a reliable option for those dealing with OSA.24678
Who Is on the Research Team?
Phillip LoSavio, MD, MS
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
HGNS Implantation and Acclimation
Participants undergo hypoglossal nerve stimulation (HGNS) implantation and acclimation to the device
Follow-up
Participants are monitored for changes in glucose metabolism and cardiovascular markers after HGNS treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hypoglossal Nerve Stimulation (HGNS)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Individuals with sleep apnea treated by HGNS therapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
Evaluating changes in hypoglossal nerve stimulator use over ...
Patients who underwent HGNS implantation for obstructive sleep apnea (OSA) from 2017 to 2023 and had available data through 9 months post-device ...
Hypoglossal nerve stimulation for obstructive sleep apnea ...
Results show that HGNS is an effective and safe treatment option. The Inspire device significantly improved, reducing the apnea-hypopnea index (AHI) by −20.14 ...
Hypoglossal Nerve Stimulation and Cardiovascular ...
In this sham-controlled HGNS randomized clinical trial, mean 24-hour systolic blood pressure and other cardiovascular measures were not significantly different ...
How we measure hypoglossal nerve stimulator outcome matters
We propose that HGNS outcomes should be assessed using full-night, single amplitude sleep studies to ensure a more accurate evaluation of HGNS therapy efficacy.
and patient-reported outcomes in hypoglossal nerve ...
The aim of this study was to directly compare these therapeutic options by standard polysomnography (PSG)-related parameters and patient-reported outcomes in ...
The outcomes of hypoglossal nerve stimulation in ...
HNS is associated with high compliance and significantly improves subjective and objective outcomes of sleep. Complications are generally uncommon and benign.
Bilateral hypoglossal nerve stimulation for obstructive sleep ...
The AHI and ODI coprimary outcome responder rates across all participants were 63.5% (73/115, P = .002) and 71.3% (82/115, P < .001), respectively using the ...
Adverse Events with Hypoglossal Nerve Stimulation in the ...
In this systematic review, HNS therapy for treatment of OSA is associated with a positive patient safety profile. AEs occur mainly at device implantation.
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