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Could a sleep headband spot Alzheimer's early?

NCT ID NCT07485153

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a wearable headband called Somfit that measures brain activity during sleep in people with early or no Alzheimer's symptoms. Researchers want to see if it works as well as a full lab sleep test. If it does, it could make it easier to track sleep changes linked to Alzheimer's at home.

What this could mean

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

Active substance
Mobile EEG device (Somfit)
What this could lead to
If successful, this could provide a simpler, at-home way to detect sleep changes linked to Alzheimer's, potentially aiding earlier diagnosis.
What could go wrong
This is a small, early-stage study with only 35 participants. The device may not match lab tests accurately, and results may not apply to all Alzheimer's 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.

Participants

About 35 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Singaporean age 55-85 with mild memory complaints or MCI who are otherwise healthy.

Ages

55 to 85 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: * Have mild cognitive impairment, subjective memory complaints, or normal cognition. * Evidence of the presence of Alzheimer's pathology as measured by amyloid positron emission tomography (PET), cerebrospinal fluid biomarkers (amyloid beta and tau), or blood biomarkers. * Montreal Cognitive Assessment (MoCA) score of 24 or greater. * Clinical Dementia Rating Scale (CDR) global score of 0 or 0.5. * Able to provide signed informed consent. * On stable medications (including those for Alzheimer's disease) for 30 days before the first recording night of Study Period 1, and willing to remain on stable therapy during the study. * Must have a study partner who knows the participant well and can accompany the participant at visits where informant-rated scales are administered. Exclusion Criteria: * Severe illness that in the investigator's judgement would adversely affect the participant's participation in the study. * Skin illness that may interfere with study assessments. * Has a pacemaker or implantable cardioverter defibrillator. * Diagnosed with a sleep disorder. * Has irregular circadian patterns (works night shifts, etc.). * Is pregnant or lactating/breastfeeding at time of screening. * Use of sleep aid medications (such as melatonin, Ambien, Lunestra) or other medications or substances that could affect sleep (alcohol, cannabinoids, or opioids) on nights of in-clinic and at-home recordings. * Currently enrolled in another clinical study involving an investigational product or other type of medical research judged not to be scientifically or medically compatible with this study. * People who habitually spend less than 5 hours in bed per night. * No alcohol will be allowed at least 24 hours before the use of the EEG and throughout the clinical assessment period.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Memory Disorders

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.

  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

  • Lilly Centre for Clinical Pharmacology

    Singapore, 138623, Singapore

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