Could a sleep headband spot Alzheimer's early?
NCT ID NCT07485153
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
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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55 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Lilly Centre for Clinical Pharmacology
Singapore, 138623, Singapore
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