Could short bursts of low oxygen ease sleep apnea and boost heart health?
NCT ID NCT05558501
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether brief, mild low-oxygen breathing sessions can improve blood vessel function, lower blood pressure, and reduce tiredness in people with obstructive sleep apnea. Researchers will enroll 60 adults aged 30-60 who are newly diagnosed and not yet using CPAP. The goal is to see if this approach can serve as a new treatment or help CPAP work better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male or female of any race, 30-60 years of age with a BMI of less than 40 kg/m2 and a weight to hip ratio of less than 1.3in males and 1.2 in females along with pure or predominantly (i.e., comprised of both a central and obstructive component)OSA (AHI less than or equal to 100 events per hour and an average oxygen desaturation level of 85 % or greater). * Participants will be newly diagnosed and not previously treated with CPAP. * Participants will also be diagnosed with hypertension. Participants will either be untreated or will be treated unsuccessfully with a single prescribed medication for hypertension. Hypertension will be classified according to the American Heart Association 2018 criteria which includes an elevated systolic blood pressure in the range of 120-129 and a diastolic pressure less than 80 mmHg in addition to stage I and stage II hypertension defined by a systolic blood pressure greater than 130 mmHg and a diastolic pressure greater than 80 mmHg. * Participants will also be included if they are pre-diabetic (HbA1C: 5.7 - 6.4 %; fasting blood glucose: 100 - 125 mg/dL) and have cholesterol levels ranging from 200-239 mg/dL. * All participants will have normal lung function and a normal EKG with no or minimal alcohol consumption (\< 2 oz of alcohol/night). * Females will be studied at similar points in their menstrual cycle. Exclusion Criteria: * Participants with baseline blood pressure greater than 160/110 will be excluded from participation. * Participants on any medications, with the exception of a single prescribed medication for individuals with resistant hypertension. * Participants with any other known disease (e.g. pulmonary hypertension). * Participants using any sleep promoting supplements including melatonin. * Night shift workers or participants who recently travelled across time zones. * Pregnant females.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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John D. Dingell VA Medical Center, Detroit, MI
RECRUITINGDetroit, Michigan, 48201-1916, United States
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