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Sleep sounds may sharpen memory in early memory loss

NCT ID NCT07402590

Symptom relief Sponsor: Bitbrain Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device that plays soft sounds during deep sleep to help memory in people with amnestic mild cognitive impairment (aMCI), a condition that often leads to Alzheimer's. 37 participants received either real or silent (placebo) sounds while sleeping. Researchers measured memory for word pairs and images before and after sleep to see if the sounds helped.

What this could mean

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

Active substance
auditory stimulation device (Elevvo AudiStim)
What this could lead to
If it works, this could offer a simple, non-drug way to improve memory for people with mild cognitive impairment.
What could go wrong
This is a very small, early study with only 37 people. The results may not apply to everyone, and the effect on memory might be small or not last.

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

37 people

The number who actually took part.

Started

May 2025

Finished

Dec 2025

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age range \> 50 years and ≤ 75 years * Native Spanish speaker * Normal or corrected-to-normal color vision * Diagnosis of Alzheimer's disease with an amnestic phenotype at the mild cognitive impairment stage, confirmed according to the current clinical criteria of NIA-AA (2024) and IWG (2024), as well as the clinical protocols of the treating hospital * Sufficient hearing without the use of a hearing aid (participant with a hearing threshold of 50 dB or higher in the calibration night hearing test will be excluded) Exclusion Criteria: * Patients with severe and/or complex chronic systemic diseases: Advanced heart disease, Advanced chronic kidney disease, for example, stage 4 or 5, Severe lung disease, such as GOLD stage III-IV COPD, Metastatic or end-stage cancer, Severe hematologic disorders, Active or chronic uncontrolled infectious diseases (e.g., untreated HIV) * Evidence of strategic infarcts or other findings on neuroimaging that could be the cause of secondary cognitive impairment * Abuse of alcohol or other psychotropic substances * Diagnosed for depression or any severe psychiatric disorder in the 5 years prior to the evaluation * Changes in treatment with benzodiazepines or antidepressants in the 6 months prior to the initial evaluation * Treatment with neuroleptics * Epilepsy with active treatment (within the last 5 years) or any comorbidity with a neurological disease that may cause cognitive impairment or brain damage * Illiteracy * Moderate or severe sleep apnea (without CPAP during the study)

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction

As listed by the trial registrant

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

Alzheimer or mild cognitive impairment Amnestic mild cognitive impairment - amci Mild cognitive impairment (MCI)

Contacts and locations

Locations

  • Bit&Brain Technologies SL

    Zaragoza, Zaragoza, 50006, Spain

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