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

Alzheimer's Disease (AD) Clinical Trial

— PINK-AD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570761
• Other study ID #: DR200077
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Tours
• Contact: Anna-Chloé BALAGEAS, PhD
• Phone: 0234378952
• Email: a.balageas[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)

Intervention

Device:
• Dreem headband
acoustic stimulation
• Dreem headband
acoustic stimulation

Locations

Country	Name	City	State
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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