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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease (AD)
• Intervention / Treatment: Device: Dreem headband

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna-Chloé BALAGEAS, PhD; Phone Number: +33 0234378952; Email: a.balageas@chu-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • University hospital of Tours
    • Sub-Investigator: Valérie GISSOT, MD
    • Contact: Anna-Chloé BALAGEAS, PhD; Phone Number: 0234378952; Email: a.balageas@chu-tours.fr
    • Principal Investigator: Anna-Chloé BALAGEAS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria common to all participants:

• Age> 50 years at the inclusion
• Patient with regular sleep patterns
• Patient having given written consent
• Patient affiliated to a social security regimen

Inclusion criteria for subjects with Alzheimer's disease:

• Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care
• MMSE score ≥ 24

Inclusion criteria for healthy volunteers:

• Absence of neurodegenerative pathologies
• Matched in age (+/- 5 years) and in sex with a patient

Non-inclusion criteria common to all participants:

• Psychiatric pathologies (except depression or anxiety disorders stabilized for more than 3 months)
• History of pathology which may have consequences on cognitive functioning and / or sleep: brain tumor, constituted stroke, epilepsy, head trauma (with clinical or parenchymal sequelae objectified on brain imagery), brain surgery
• Any significant comorbidity likely to constitute a confounding factor according to the clinician
• Psychotropic treatments introduced or modified <3 months before inclusion
• Hypnotic and / or sedative treatments
• Chronic consumption of alcohol or drugs
• Legal incapacity and / or other circumstance rendering the patient unable to understand the nature, objective or consequences of the study
• Major under guardianship or curatorship
• Patient not French-speaking by birth or illiterate

Exclusion Criteria common to all participants:

• Sleep disorders defined by a score> 5 on the Pittsburg sleep quality index (PSQI)
• A score> 10 on the Epworth sleepiness index

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ON-Stim; acoustic stimulation	Device: Dreem headband; acoustic stimulation
Sham Comparator: OFF-Stim; no acoustic stimulation	Device: Dreem headband; acoustic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 7
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.	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.	Day 8
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.	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.	Day 14
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.	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.	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.	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 ecological memory task.	Day 7
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.	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 ecological memory task.	Day 8
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.	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 ecological memory task.	Day 14
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.	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 ecological memory task.	Day 15
The memory complaint for Mc Nair's Questionnaire	score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.	Baseline
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)	score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.	Baseline
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)	score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.	Baseline
Quality of sleep for Pittsburgh Index (PSQI)	It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.	Baseline
The memory complaint for Mc Nair's Questionnaire	score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.	Day 15
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)	score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.	Day 15
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)	score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.	Day 15
Quality of sleep for Pittsburgh Index (PSQI)	It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.	Day 15
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition	gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device	Day 7
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition	gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device	Day 8
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition	gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device	Day 14
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition	gross variation in the amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition, on an ambulatory EEG device	Day 15

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: DR200077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No