Recruiting

Predicting which sleep apnea patients will benefit from nerve stimulation therapy

Plain-English translation of NCT05429983 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

What is this trial?

This trial is studying whether specific airway measurements taken during a sleep procedure can predict which patients will benefit from the Inspire hypoglossal nerve stimulation device. The device is a surgically implanted system designed to help people with sleep apnea who cannot tolerate traditional CPAP machines. Researchers want to understand which patients will have the best outcomes with this treatment.

While the Inspire device is FDA-approved and helps many people with sleep apnea, about one-third of patients who receive it don't see significant improvement. This study aims to identify predictive markers during a standard evaluation procedure so doctors can better select which patients are most likely to benefit from this treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with moderate to severe sleep apnea (more than 15 breathing pauses per hour during sleep)
you have tried CPAP therapy and found it ineffective or intolerable
you are undergoing a drug-induced sleep endoscopy procedure as part of routine evaluation for nerve stimulation therapy or to evaluate why an existing device isn't working well
you are male or female, of any age

You likely don't qualify if…

you have significant heart disease or have had recent cardiac events
you have uncontrolled high blood pressure (above 160/100)
you are currently taking blood-thinning medications like Coumadin or Dabigatran
you have active lung, liver, kidney disease or neuromuscular conditions
you are pregnant or have major psychiatric illness

What participation looks like

You will participate in a drug-induced sleep endoscopy procedure, which is already part of standard care for evaluating nerve stimulation therapy. During this procedure, researchers will take additional measurements of how your airway responds to direct nerve stimulation and varying air pressures. After you receive the implanted device (if you proceed with treatment), the study team will track your outcomes to see if the measurements predicted your response to therapy.

Predicting which sleep apnea patients will benefit from nerve stimulation therapy

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)