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Can a night-time breathing device boost brain power in older vets with lung and sleep troubles?

NCT ID NCT04179981

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether using a positive airway pressure (PAP) machine at night can improve thinking, sleepiness, and quality of life in older veterans (age 60+) who have both COPD and obstructive sleep apnea—a combination called Overlap Syndrome. About 668 participants will be randomly assigned to either PAP therapy or usual care with sleep education. The main focus is on changes in memory, attention, and daily function over time.

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 it works, this could show that using a breathing machine at night helps older veterans with both COPD and sleep apnea think clearer, sleep better, and feel better day-to-day.
What could go wrong
This is a large but early-stage trial focused on measuring outcomes, not a cure. Results may show only small improvements, and some people may find the mask uncomfortable or hard to use regularly.

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 668 people

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

Started

Dec 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

60 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: * OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\>10 pack-years) of smoking * Male or female gender * Age greater than or equal to 60 years * Stable treatment regimen for COPD Exclusion Criteria: * Current or prior treatment with PAP or oral appliance * Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI * Known primary neuromuscular diseases * Disorders that may impact cognitive function including: * neurodegenerative disorders * traumatic brain injury * untreated PTSD and/or history of learning disability * Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results * Patient is actively suicidal due to depression, unstable mental health condition * Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months * Narcolepsy is the primary sleep disorder, with requirement of stimulant medications * Employed as a commercial driver or operating heavy machinery * On long-term oxygen therapy prior to start of study, more than 12 hr/day * Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia) * Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits * Patients who cannot give informed consent * Patients receiving hospice care * Pregnant women due to unknown risks

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Conditions

The condition(s) this trial relates to.

Apnea chronic obstructive pulmonary disease COPD, severe early onset mixed connective tissue disease nervous system disorder obstructive sleep apnea syndrome overlapping connective tissue disease Respiration Disorders respiratory system disorder Signs and Symptoms, Respiratory sleep apnea syndrome Sleepiness

As listed by the trial registrant

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

COPD Elderly Neurocognitive function Obstructive sleep apnea Overlap syndrome Positive airway pressure Quality of life Sleep apnea syndrome Sleepiness

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

  • John D. Dingell VA Medical Center, Detroit, MI

    RECRUITING

    Detroit, Michigan, 48201-1916, United States

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