NCT07402590Completed
Auditory Stimulation During Sleep to Enhance Long-Term Memory in Amnestic MCI
Randomized, Double-Blind, Placebo-Controlled Investigation to Validate the Efficacy and Safety of an Auditory Stimulation Treatment During Sleep to Improve Cognitive Abilities Related to Long-Term Memory in Amnestic Mild Cognitive Impairment (aMCI)
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of Elevvo AudiStim, a sleep auditory stimulation device, as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 17 Mar 2025
- Start date
- 6 May 2025
- Primary completion date
- 24 Dec 2025
- Lead sponsor
- Bitbrain
- Diseases
- Alzheimer disease
- NCT number
- NCT07402590
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 6 May 2025 to the primary completion date, 24 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Epilepsy with active treatment (within the last 5 years) or any comorbidity with a neurological disease that may cause cognitive impairment or brain damage
Other
- Abuse of alcohol or other psychotropic substances
- Illiteracy
- Moderate or severe sleep apnea (without CPAP during the study)
Who the study is looking for
- 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)
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bit&Brain Technologies SL Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.