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

NCT07402590 | Completed

• 2 other identifiers: P-4-ASC.I PI24/517
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MCI; auditory stimulation; amnestic mild cognitive impairment (aMCI); sleep; memory consolidation; alzheimer disease

Outcome Measures

Primary Outcomes (2)

• Performance (pre vs post-sleep) in a word pair association task

  Memory performance in this task is measured as the number of word pairs recalled during morning and long-term recall, subtracted from the number of word pairs indicated during immediate recall. This metric will be compared between the two experimental conditions.

  Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).

• Performance (pre vs post-sleep) in a visuospatial memory task

  Memory performance is measured as the number of recognized images and correctly indicated image locations during morning and long-term recall, subtracted from the respective numbers during immediate recall. This metric will be compared between the two experimental conditions.

  Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).

Secondary Outcomes (7)

• Working memory performance

  Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2).

• Slow wave and sleep spindle activity

  Throughout Nights 1/2.

• Sleep macrostructure - Total Sleep Time

  Throughout Nights 1/2.

• Sleep macrostructure - Percentage of Time per Sleep Stage

  Throughout Nights 1/2.

• Sleep macrostructure - Sleep Efficiency

  Throughout Nights 1/2.

Study Arms (2)

Auditory stimulation first

OTHER

This arm receives auditory stimulation in the first experimental night ("Night 1") and placebo stimulation in the second night ("Night 2").

Procedure: Auditory Stimulation; Procedure: Placebo stimulation

Placebo stimulation first

OTHER

This arm receives placebo stimulation in the first experimental night ("Night 1") and auditory stimulation in the second night ("Night 2").

Procedure: Auditory Stimulation; Procedure: Placebo stimulation

Interventions

Auditory Stimulation PROCEDURE

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.

Also known as: Elevvo Audistim

Auditory stimulation first; Placebo stimulation first

Placebo stimulation PROCEDURE

All procedures are identical to the Auditory stimulation condition but the tone volume is set to 0.

Auditory stimulation first; Placebo stimulation first

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bitbrain: lead
• Hospital Miguel Servet: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Hospital Royo Villanova de Zaragoza: collaborator

Study Sites (1)

Bit&Brain Technologies SL

Zaragoza, Zaragoza, 50006, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: February 11, 2026
• Study Start: May 6, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 31, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)