Could a nighttime sound machine help fight Alzheimer's?
NCT ID NCT07672977
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study tests whether a device that plays brief, soft sounds during deep sleep can enhance brain wave activity in people with mild cognitive impairment due to Alzheimer's disease. Participants use the device at home each night for three months, with an optional three-month extension. The goal is to see if the stimulation safely and consistently increases slow-wave activity, a brain pattern linked to memory and thinking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Closed-loop auditory stimulation device (AudiStim)
- What this could lead to
- If it works, this could point toward a non-drug way to improve sleep-related brain function and possibly slow memory decline in early Alzheimer's.
- What could go wrong
- This is a small, early proof-of-concept study with no placebo group, so results may not be conclusive. The device may not produce lasting benefits or work for everyone.
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
-
Jul 2025
- Expected to finish
-
Dec 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.
- Ages
-
50 to 75 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 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: * Age between 50 and 75 years (inclusive). * Spanish as native language. * Diagnosis of amnestic mild cognitive impairment due to Alzheimer's disease, confirmed by cerebrospinal fluid biomarkers or amyloid PET. * Normal or corrected-to-normal color vision (required for completion of visual-analog study assessments). * Adequate hearing to perceive the auditory stimuli used in the intervention, defined as a hearing threshold of 50 dB or below, assessed during the screening session. Exclusion criteria: * Severe systemic or complex chronic disease that, in the investigator's judgment, would compromise participant safety or data quality, including but not limited to: advanced heart disease; advanced chronic kidney disease (stage 4 or 5); severe pulmonary disease (e.g., COPD GOLD stage III-IV); metastatic or terminal cancer; severe hematological disorders; or active or uncontrolled chronic infectious disease (e.g., untreated HIV). * Evidence on neuroimaging of strategic infarcts or other findings that may account for secondary cognitive impairment. * Alcohol or psychotropic substance abuse. * Diagnosis of depression or any severe psychiatric disorder within the 5 years prior to evaluation. * Changes in benzodiazepine or antidepressant treatment within the 6 months prior to baseline evaluation. * Current treatment with neuroleptics. * Epilepsy with active treatment within the last 5 years, or any neurological comorbidity that may cause cognitive impairment or structural brain damage. * Unable to read and write in Spanish. * Inability to use the study device effectively, as determined during the screening session. This includes, but is not limited to, anatomical or dermatological factors preventing adequate electrode placement, or excessive EEG signal artifacts that prevent reliable detection of sleep oscillations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AD are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
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
-
Bit&Brain Technologies SL
Zaragoza, Zaragoza, 50006, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a home device slow dementia? pilot trial tests pulsed electromagnetic therapy
- Can a video chat keep dementia care true to Patients' wishes?
- 10-Year watch: how safe is lecanemab outside clinical trials?
- Can a Melatonin-Like pill slow Alzheimer's memory loss?
- Could brain stimulation help Alzheimer's patients think more clearly?
- Could a common blood pressure pill recharge brain cells in Alzheimer's?