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Blood markers may reveal sleep apnea and treatment success

NCT ID NCT04572269

Knowledge-focused Sponsor: University of Pennsylvania 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study looked at whether chemicals in the blood (metabolomics) can help diagnose obstructive sleep apnea and track changes with treatment. Researchers analyzed stored blood samples from 388 people with and without sleep apnea, and also collected new samples from patients using CPAP therapy. The goal was to find a blood-based signature that correlates with sleep apnea severity and treatment adherence.

What this could mean

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

What this could lead to
If successful, this could lead to a simple blood test to diagnose sleep apnea and monitor how well treatment is working.
What could go wrong
This is an observational study using existing samples and real-world data, so results may not be definitive. It does not test a new treatment or intervention.

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.

Participants

388 people

The number who actually took part.

Started

Sep 2020

Finished

Sep 2025

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.

Who is studied

Prospective recruitment of female and male OSA subjects n=500/site: Site #1 is University of Pennsylvania; Site #2 is University of Iceland for a total of n=1000 cases.

Ages

30 to 75 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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 30-75 years old 4. In good general health as evidenced by medical history and diagnosed with Obstructive Sleep Apnea (defined as AHI\>5) 5. Ability to use accelerometer, perform Type 2 sleep test at home and agree to use PAP treatment. 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. Exclusion Criteria: 1. Current use of PAP treatment or mandibular advancement device or INSPIRE device 2. Presence of active cancer treatment or heart failure (ejection fraction \<40%) 3. Pregnancy or lactation 4. Known allergic reactions to components of the plastic (used in PAP mask) 5. Febrile illness within 2 weeks of signing consent 6. Current drug or alcohol abuse 7. Known diagnosis and treatment of diabetes because this will independently alter metabolomic results. 8. Previously drawn laboratory Hemoglobin A1C above normal range (indicative of diabetes).

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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.

Obstructive sleep apnea

Contacts and locations

Locations

  • University of Iceland

    Reykjavik, 108, Iceland

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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