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

NCT ID: NCT04570761

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2024-03-31

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.

Conditions

Alzheimer's Disease (AD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ON-Stim

acoustic stimulation

Group Type: EXPERIMENTAL

Dreem headband

Intervention Type: DEVICE

acoustic stimulation

OFF-Stim

no acoustic stimulation

Group Type: SHAM_COMPARATOR

Dreem headband

Intervention Type: DEVICE

acoustic stimulation

Interventions

Dreem headband

acoustic stimulation

Intervention Type: DEVICE

Dreem headband

acoustic stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

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

• 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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Tours

Tours, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Anna-Chloé BALAGEAS, PhD

Role: CONTACT

a.balageas@chu-tours.fr

0234378952 ext. +33

Facility Contacts

Anna-Chloé BALAGEAS, PhD

Role: primary

a.balageas@chu-tours.fr

0234378952

Other Identifiers

DR200077

Identifier Type: -

Identifier Source: org_study_id