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

June 12, 2026 updated by: University Hospital, Tours

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Tours, France, 37044
        • University Hospital of TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Day 7
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.
Time Frame: Day 8
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.
Time Frame: Day 14
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.
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.
Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: Day 7
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.
Time Frame: Day 8
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.
Time Frame: Day 14
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.
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 ecological memory task.
Day 15
The memory complaint for Mc Nair's Questionnaire
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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
Time Frame: Day 15
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)
Time Frame: Day 15
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)
Time Frame: Day 15
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)
Time Frame: Day 15
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
Time Frame: Day 7
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
Time Frame: Day 8
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
Time Frame: Day 14
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
Time Frame: Day 15
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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