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Auditory Stimulation During Sleep to Enhance Long-Term Memory in Amnestic MCI

NCT07402590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-02-11

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Miguel Servet

    collaborator OTHER

  • Hospital Clínico Universitario Lozano Blesa

    collaborator OTHER

  • Hospital Royo Villanova de Zaragoza

    collaborator UNKNOWN

  • Bitbrain

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2025-12-24
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07402590 on ClinicalTrials.gov