Predicting outcomes in patients with obstructive sleep apnea using hypoglossal nerve stimulation
Assessing Stimulated Upper Airway Mechanics to Predict Outcomes in Hypoglossal Nerve
This study is trying to figure out how the upper airway works in people with obstructive sleep apnea to see why some don’t respond well to a specific treatment called hypoglossal nerve stimulation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05429983 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize upper airway biomechanics and identify predictors of clinical responses to hypoglossal nerve stimulation (HGNS) therapy in patients with obstructive sleep apnea (OSA). Participants will include individuals undergoing drug-induced sleep endoscopy (DISE) as part of their evaluation for HGNS therapy. The study seeks to improve understanding of why some patients do not respond adequately to HGNS, despite being selected based on strict criteria. By analyzing upper airway mechanics, the study hopes to enhance patient selection and treatment outcomes for those intolerant to CPAP.
Who should consider this trial
Good fit: Ideal candidates are males and females with moderate to severe obstructive sleep apnea who are undergoing DISE for HGNS evaluation.
Not a fit: Patients with significant cardiac, pulmonary, liver, or renal diseases, uncontrolled hypertension, neuromuscular diseases, major psychiatric disorders, or those who are pregnant or on anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for HGNS therapy, enhancing treatment outcomes for those with obstructive sleep apnea.
How similar studies have performed: While there have been studies on hypoglossal nerve stimulation, this specific approach focusing on upper airway biomechanics and predictors of response is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants with moderate or severe sleep apnea (defined by \> 15 apneas and hypopneas per hour of sleep), who are undergoing DISE as part of routine evaluation for Inspire hypoglossal nerve stimulation therapy or for ineffective HGNS therapy. Exclusion Criteria: * Significant cardiac disease, unstable or recent cardiac events * Active pulmonary, liver or renal disease * Uncontrolled hypertension (BP\>160/100) * Neuromuscular disease * Major psychiatric disease * Pregnancy * Anticoagulation therapy (e.g. Coumadin, Dabigatran)
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kevin Motz, MD — Johns Hopkins University
- Study coordinator: Kevin M Motz
- Email: kmotz1@jh.edu
- Phone: 410614245
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.