NCT07402590

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bitbrain · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Amnestic Mild Cognitive Impairment (aMCI) is a precursor of dementia that involves memory impairment as a primary symptom. The condition presents a valuable opportunity for intervention before a potential progression to more severe, life-altering stages. A technique called "auditory stimulation during sleep" has previously been shown to improve memory by triggering neural oscillations such as slow waves and sleep spindles, which are implicated in memory processing. We hypothesize that the technique might improve memory also in patients with aMCI. This investigation is thus designed to systematically assess both the product's efficacy as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI) and its overall safety profile. After an initial calibration night ("Night 0"), two experimental nights will be performed ("Night 1" and "Night 2"), separated by 14 days. 7 days after each experimental night, a daytime long-term follow-up will be performed ("LT1" and "LT2"). Participants will receive either real or sham auditory stimulation during sleep, such that all participants will participate in both these conditions in a randomized balanced order.

Conditions

• Mild Cognitive Impairment (MCI)
• Amnestic Mild Cognitive Impairment - aMCI
• Alzheimer or Mild Cognitive Impairment

Interventions

Type	Name	Description
PROCEDURE	Auditory Stimulation	Brief auditory stimuli (50-ms bursts of pink noise) are delivered to patients once they have entered stable non-rapid eye movement (NonREM) sleep. The volume is automatically adjusted to optimize the induction of targeted neural oscillations, specifically slow waves and sleep spindles, while minimizing the risk of arousal.
PROCEDURE	Placebo stimulation	All procedures are identical to the Auditory stimulation condition but the tone volume is set to 0.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-12-24
• Completion: 2025-12-31
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Spain