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Thin tube could map sleep apnea blockages better than scopes

NCT ID NCT04139499

Knowledge-focused Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a thin, flexible tube with pressure sensors (high-resolution manometry) can pinpoint where the airway gets blocked during sleep in people with obstructive sleep apnea. 18 adults and children underwent both the standard scope test and the new tube method. The goal was to see if the tube could provide clearer, more detailed information about blockages at different spots in the throat.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this works, it could give doctors a more precise, objective way to find where the airway is blocked during sleep, helping plan better surgeries for sleep apnea.
What could go wrong
This was a very small, early study with only 18 people. The new method may not prove more useful than current techniques, and results may not apply to everyone with sleep apnea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Jan 2019

Finished

May 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Majority of subjects will be those children and adults who will be undergoing DISE as part of their standard clinical care. However, it is desirable to have cleaner controls without obstruction at any level to confirm that the visual absence of obstruction also represents a manometrically normal respiration. Thus, subjects without symptoms of obstructive sleep apnea who are undergoing a surgical procedure will be recruited. Simultaneous performance of DISE (to confirm no obstruction) and HRM in such subjects would take about 5 minutes. Further, the time required is within the variability typically expected at an academic center where trainees may participate in cases.

Ages

5 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: ADULTS * Age 18-90 * Any participant undergoing sleep endoscopy as part of standard clinical care would be eligible. This entails physician concern for sleep-disordered breathing and corresponding questionnaire and/or polysomnogram results supporting a diagnosis of obstructive sleep apnea. * Participants without apnea are eligible, provided they are undergoing tonsillectomy or bronchoscopy for either chronic tonsillitis or airway assessment without concern for history of sleep apnea. * Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential. CHILDREN * Age 5-17 * Any patients undergoing sleep endoscopy as part of standard clinical care would be eligible. * Participants undergoing either tonsillectomy for chronic tonsillitis or bronchoscopy for airway assessment. * Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential. Exclusion Criteria: * Participant desire to avoid added anesthesia time. * Inability to safely tolerate the added anesthesia time (about 5-10 minutes) for the experiment (as judged by either otolaryngologist or anesthesiologist). * Pregnant women * Vulnerable groups (i.e., prisoners, individuals lacking consent capacity, individuals unable to read the consent form).

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome tonsillitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstructive sleep apnea

Contacts and locations

Locations

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.