CompletedNot Applicable

Mechanisms of Upper Airway Obstruction

United States133 participantsStarted 2020-06-03

Plain-language summary

The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Study A Inclusion Criteria: • Scheduled to undergo DISE as part of routine clinical standard of care. Study B Inclusion Criteria: * Adults (≥ 22yrs) willing and capable of providing informed consent * Implanted with the MRI-conditional Inspire hypoglossal nerve stimulator (Model 3028 or later) * Compliant with Inspire therapy (\> 20 hours/week over 2+ weeks) as a standalone treatment for sleep-disordered breathing * Inspire remote model 2500 or later. Study B Exclusion Criteria: * MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.) * Inspire Implant Model 3024 * Inspire Remote Model 3032 * Patients who have fallen asleep while during resulting in an accident or "near miss" accident within 1 year prior to device implantation. * Inability to sleep in the supine position (by self-report) * History of severe difficulty initiating or maintaining sleep in the laboratory * Pregnant women

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharyngeal Critical Pressure (Pcrit)

Timeframe: Collected during drug-induced sleep endoscopy (<1 day).

Pharyngeal Opening Pressure (PhOP)

Timeframe: Collected during drug-induced sleep endoscopy (<1 day).

Pharyngeal Compliance

Timeframe: Unable to be determined

Trial details

NCT IDNCT04322097

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-10

Results submitted2025-08-08

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.