Breathing brief Low-Oxygen bursts may boost sleep apnea treatment

NCT ID NCT03736382

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether short, repeated sessions of mild low oxygen (mild intermittent hypoxia) can strengthen upper airway muscles and improve sleep apnea treatment. Adults with newly diagnosed obstructive sleep apnea and prehypertension or stage 1 hypertension, including some with spinal cord injuries, receive either the mild hypoxia or a sham (room air) protocol five days a week for three weeks, while all use CPAP every night. The study measures changes in blood pressure over 24 hours and during sleep, along with metabolic and cognitive outcomes, to see if this combined approach helps.

What this could mean

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

Active substance
mild intermittent hypoxia (brief, controlled low-oxygen breathing sessions)
What this could lead to
If it works, this approach could reduce how much CPAP pressure people need and might improve blood pressure and other health measures tied to sleep apnea.
What could go wrong
The trial is small and early, so results may not hold up in larger groups. Mild intermittent hypoxia can cause temporary discomfort, and its effects on blood pressure and sleep are still uncertain.

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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

47 people

The number who actually took part.

Started

Nov 2018

Finished

Jun 2026

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 to 60 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: * Body mass index \< 40 kg/m\^2. * 18 to 60 years old. * Newly diagnosed sleep apnea (i.e. apnea/hypopnea index \< 100 events per hour - average nocturnal oxygen saturation \> 85 %) that has not been treated. * Diagnosed with prehypertension or Stage 1 hypertension as categorized by the American Heart Association * Not pregnant. * Normal lung function. * Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day) * A typical sleep/wake schedule (i.e. participants will not be night shift workers or have recently travelled across time zones). * For spinal cord injured participants (Aim-2): incomplete spinal cord lesions at C3 or below and above T12 (greater than 36 mos. post-SCI) without joint contractures but with signs of voluntary ankle, knee and hip movements and the ability to ambulate at least one step without human assistance. Exclusion Criteria: * Any disease other than high blood pressure and sleep apnea. * Medications for high blood pressure and sleep promoting supplements including melatonin * Current effective CPAP usage (greater than 4 hours per night). * Night Shift workers or recently traveled across time zones.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • John D Dingell VA Medical Center

    Detroit, Michigan, 48201, United States

  • Wayne State University

    Detroit, Michigan, 48201, United States

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