Predicting outcomes in patients with obstructive sleep apnea using hypoglossal nerve stimulation

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.