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Sleep and exercise may fight Alzheimer's, small study hopes

NCT ID NCT04855630

Knowledge-focused Sponsor: University of Miami 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether improving sleep with a special headband and doing mild exercise twice a week can lower biological markers linked to dementia. Thirty adults with mild memory or thinking problems will use the DREEM 2 headband for sleep therapy and follow a guided exercise routine for three months. Researchers will measure changes in cholesterol, blood sugar, inflammation, and stress hormones to see if these lifestyle changes might reduce Alzheimer's risk.

What this could mean

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

Active substance
DREEM 2 headband with CBT-I and guided exercise routine
What this could lead to
If successful, this could show that combining sleep therapy and exercise lowers dementia risk markers, pointing toward a simple lifestyle-based approach to slow Alzheimer's.
What could go wrong
This is a very small, early-stage study with only 30 participants and no control group. It measures biomarkers, not actual dementia prevention, so results may not lead to a proven treatment.

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 30 people

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

Started

Mar 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

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

45 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: 1. Able to perform mild exercise 2. Able to wear DREEM 2 Headband 3. Able to wear a Fitbit wrist watch 4. Able to perform the Everlywell biomarker procedure 5. Able to Understand and Speak English 6. Able to operate a digital device like mobile phone, iPad, or computer 7. Self-reported history of problems with cognitive impairment: memory, concentration, and processing information 8. Only participants cognitively able and willing to provide consent will be included. Exclusion Criteria: 1. Prohibited from or unable to perform mild exercise 2. Unable to wear wrist watch or headband devices, or unable to supply pinprick blood sample for any reason 3. Unable to speak or understand English 4. Unable to use mobile device/smartphone technology 5. Unable or unwilling to consent for any reason.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia

As listed by the trial registrant

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

Alzheimer disease Dementia

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

  • University of Miami Hospitals

    RECRUITING

    Miami, Florida, 33136, United States

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