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New nasal tube could help sleep apnea sufferers ditch CPAP

NCT ID NCT06677151

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a flexible silicone tube that people insert into one nostril before sleep to keep their airway open. It's for adults with moderate to severe obstructive sleep apnea who cannot tolerate CPAP machines. Twenty participants will use the device for 30 days to see if it reduces apnea events and is comfortable enough for daily use.

What this could mean

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

Active substance
nasopharyngeal airway obstructive sleep apnea (NPA-OSA) device
What this could lead to
If successful, this device could offer a new, more comfortable option for people with sleep apnea who struggle with CPAP machines.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply to everyone. The device must be self-inserted nightly, which may be difficult or uncomfortable for some.

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 20 people

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

Started

Mar 2025

Expected to finish

Dec 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

18 years and older

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: * Capacity and willingness to sign consent * Patient willingness to commit to and complete study over a 30-day time period * Confirmed diagnosis of moderate to severe OSA (AHI \>= 15) * OSA caused by upper airway obstruction * CPAP non-compliant where CPAP compliance is defined as using CPAP for at least 4 hours a night for at least 70% of nights or interest in an alternative sleep apnea therapy * Adequate manual dexterity to demonstrate ability to self-insert and remove device Exclusion Criteria: * Within 3 months of initiating CPAP use, and actively using CPAP * Supraglottic airway collapse * Distal airway stenosis * Tracheobronchomalacia * Currently pregnant * Active COVID-19 infection * Need for anticoagulative therapy * Severe nasal allergies * Bleeding disorder * More than mild elevation of End-tidal carbon dioxide (ETCO2) or total carbon dioxide (TCO2) values \>60 mmHg for \>10% of sleep time * Restrictive thoracic disorders * Silicone, lidocaine, neosynephrine allergy * Recurrent epistaxis * Uncontrolled or serious illness, included but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Sleep apnea, obstructive

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Michigan Medicine

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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