search
Back to results

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

Primary Purpose

Alzheimer's Disease (AD)

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dreem headband
Dreem headband
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease (AD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ON-Stim

OFF-Stim

Arm Description

acoustic stimulation

no acoustic stimulation

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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

Full Information

First Posted
September 8, 2020
Last Updated
October 3, 2023
Sponsor
University Hospital, Tours
search

1. Study Identification

Unique Protocol Identification Number
NCT04570761
Brief Title
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Acronym
PINK-AD
Official Title
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ON-Stim
Arm Type
Experimental
Arm Description
acoustic stimulation
Arm Title
OFF-Stim
Arm Type
Sham Comparator
Arm Description
no acoustic stimulation
Intervention Type
Device
Intervention Name(s)
Dreem headband
Intervention Description
acoustic stimulation
Intervention Type
Device
Intervention Name(s)
Dreem headband
Intervention Description
acoustic stimulation
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 7
Title
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.
Description
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.
Time Frame
Day 8
Title
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.
Description
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.
Time Frame
Day 14
Title
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.
Description
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.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Description
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.
Time Frame
Day 7
Title
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Description
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.
Time Frame
Day 8
Title
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Description
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.
Time Frame
Day 14
Title
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
Description
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.
Time Frame
Day 15
Title
The memory complaint for Mc Nair's Questionnaire
Description
score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Baseline
Title
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
Description
score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Baseline
Title
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
Description
score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Baseline
Title
Quality of sleep for Pittsburgh Index (PSQI)
Description
It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.
Time Frame
Baseline
Title
The memory complaint for Mc Nair's Questionnaire
Description
score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Day 15
Title
Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
Description
score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Day 15
Title
Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
Description
score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.
Time Frame
Day 15
Title
Quality of sleep for Pittsburgh Index (PSQI)
Description
It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.
Time Frame
Day 15
Title
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Description
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
Time Frame
Day 7
Title
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Description
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
Time Frame
Day 8
Title
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Description
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
Time Frame
Day 14
Title
amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
Description
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
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna-Chloé BALAGEAS, PhD
Phone
0234378952
Ext
+33
Email
a.balageas@chu-tours.fr
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Chloé BALAGEAS, PhD
Phone
0234378952
Email
a.balageas@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Anna-Chloé BALAGEAS, PhD
First Name & Middle Initial & Last Name & Degree
Valerie GISSOT, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs