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New study aims to uncover why sleep apnea harms the heart and brain

NCT ID NCT04575740

Knowledge-focused Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 209 adults with moderate to severe sleep apnea to better understand how the condition affects the body. Instead of just counting breathing pauses, researchers used special measures like oxygen drops, heart rate changes, and sleep disruption. Participants used a CPAP machine for 12 weeks, and the team tracked changes in blood vessel health, blood pressure, and sleepiness. The goal was to find better ways to predict and prevent heart and brain problems linked to sleep apnea.

What this could mean

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

Active substance
Positive airway pressure (PAP) device
What this could lead to
If successful, this could lead to better ways to predict and prevent heart and brain problems in people with sleep apnea.
What could go wrong
This is a small, completed study focused on measuring health effects, not testing a new treatment. The findings may not change current care or apply to all patients.

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

209 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.

Ages

21 to 80 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: * Adults aged 21-80 years. * Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation. Exclusion criteria: * Current treatment for obstructive sleep apnea (including CPAP, oral appliances, supplemental oxygen). Patients must be untreated prior to the baseline visit. * Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon). * Active use of non-prescription opioids (e.g., cocaine, methamphetamine) * Uncontrolled medical problem or major organ system disease, which, in the opinion of the investigators (PI and Co-Is), would interfere with the evaluation of the subject (e.g., uncontrolled hypertension, unstable coronary heart disease, etc.). * History of congestive heart failure, renal insufficiency, systemic neurological condition that could affect respiration. * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: * central sleep apnea (\>50% of respiratory events scored as central), * chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions. * Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias. * Patients unable or unwilling to use CPAP. * Insomnia or insufficient sleep (self-reported inability to sleep \>6 hrs night). * Pregnancy (women)

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Sleep apnea

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.