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Clinical Trials/NCT04570761
NCT04570761
Recruiting
N/A

Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study

University Hospital, Tours1 site in 1 country30 target enrollmentMarch 11, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer's Disease (AD)
Sponsor
University Hospital, Tours
Enrollment
30
Locations
1
Primary Endpoint
difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex.

A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option.

The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.

Detailed Description

Alzheimer's disease (AD) is a neurodegenerative disorder affecting almost 6% of the world's population over the age of 65. This disease, in its most typical sporadic form, is characterized by an episodic memory impairment linked to a deficit in consolidation. Many studies indicate that sleep promotes this consolidation stage during the deep slow sleep stage by facilitating the transfer of information between the hippocampus and the neocortex. A method of acoustic brain stimulation at night by pink noises has been recently developed and has shown its effectiveness in strengthening memory consolidation in healthy volunteers. Actually, there is no study observing the effect of this new stimulation method on populations with neurodegenerative pathologies, in particular in AD for which this technique could potentially become a therapeutic option. The hypothesis is that of a strengthening of the memory consolidation capacities in subjects with AD as has been shown in healthy subjects.

Registry
clinicaltrials.gov
Start Date
March 11, 2021
End Date
March 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.

Time Frame: Day 15

gross variation of the difference between morning and eve of the number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the memory task of word matching.

Secondary Outcomes

  • amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition(Day 15)
  • The memory complaint for Mc Nair's Questionnaire(Day 15)
  • Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)(Day 15)
  • Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)(Day 15)
  • Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.(Day 15)
  • Quality of sleep for Pittsburgh Index (PSQI)(Day 15)

Study Sites (1)

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