Cure My Disease

Don't miss your cure!

 Log in / Sign up

Nasal tube offers hope for kids with sleep apnea due to muscle weakness

NCT ID NCT06614582

Disease control Sponsor: University of Michigan 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows children with hypotonia (low muscle tone) who have obstructive sleep apnea. They use a flexible silicone nasal tube called ssNPA at night to keep the airway open. Researchers will check how well it works and if children can tolerate it over a year.

What this could mean

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

Active substance
Self-Supporting Nasopharyngeal Airway (ssNPA) device
What this could lead to
If successful, this could provide a long-term, non-surgical option to manage obstructive sleep apnea in children with hypotonia.
What could go wrong
This is a small, single-arm follow-up study with only 40 participants. The device may be uncomfortable or not effective for all children, and results may not apply to broader populations.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Ages

3 to 23 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children with Hypotonic Upper Airway Obstruction (HUAO) that took part in the original study (HUM00189669/NCT04846400 or HUM00220966/NCT05527652 trials) * Willingness to continue device usage. * Confirmed diagnosis of OSA (apnea/hypopnea index; AHI \> 10 or AHI \>5 with lowest oxygen level ≤75%) * At least one symptom of OSA (such as frequent snoring, daytime sleepiness, or hyperactive/inattentive behaviors) * Previous adenotonsillectomy (unless tonsillectomy not possible) * Tonsil size 2+ or smaller Exclusion Criteria: * Participants that were non-compliant with the Self-Supporting Nasopharyngeal Airway (ssNPA) device during participation in the parent study listed above * Any medical reason why ssNPA therapy may not be suitable * Active COVID 19 infections Moderate/severe tracheobronchomalacia * Need for anticoagulative therapy * Bleeding disorder * Restrictive thoracic disorders

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypotonia, muscle are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

cerebral palsy Down syndrome Dyspnea Muscle Hypotonia Nasal Obstruction obstructive sleep apnea syndrome

As listed by the trial registrant

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

Hypotonia, muscle Nasal airway obstruction Obstructive sleep apnea

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

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