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Can a sleep apnea machine help people with collapsing airways walk farther?

NCT ID NCT04217603

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a CPAP machine during a 6-minute walk test helps people with excessive central airway collapse (ECAC) walk farther and feel less breathless. ECAC is a condition where the central airways narrow or collapse during breathing, making exercise difficult. Researchers will compare CPAP to a sham device in 32 adults, measuring walking distance, breathing effort, and cough. CPAP is already FDA-approved for sleep apnea but not for ECAC.

What this could mean

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

Active substance
Continuous positive airway pressure (CPAP) device
What this could lead to
If it works, CPAP could become a non-invasive way to improve exercise capacity and reduce shortness of breath in people with excessive central airway collapse.
What could go wrong
This is a small, early-stage trial with only 32 participants. CPAP is not yet approved for this condition, and the sham comparison may show no meaningful benefit.

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 32 people

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

Started

Mar 2023

Expected to finish

Sep 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: * Patient with a diagnosis of ECAC either via bronchoscopy or CT Scan * Age \> 18 years * Patients that will undergo a diagnostic or therapeutic bronchoscopy as part of their standard of care * Patients with a baseline 6 MWT * Patients that have never used CPAP devices in the past Exclusion Criteria: * Patients with poorly-controlled respiratory comorbidities (asthma, COPD, obstructed sleep apnea, GERD, relapsing polychondritis) * No evidence for acute respiratory tract infection, or respiratory tract infection within the prior 3 weeks * Resting bradycardia (\<50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT * Dysrhythmia that might pose a risk during exercise or training * Any disease or condition that interferes with completion of initial or follow-up assessments * Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea. * Subject has an inability to walk \>140m (150 yd) in 6 minutes * Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia. * Subject has a known sensitivity to drugs required to perform bronchoscopy.

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Conditions

The condition(s) this trial relates to.

congenital tracheomalacia Tracheobronchomalacia

As listed by the trial registrant

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

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

    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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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