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

NCT04570761 | Unknown

• 1 other identifier: DR200077
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• 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.

  Day 8

• 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.

  Day 15

• The memory complaint for Mc Nair's Questionnaire

  Baseline

Study Arms (2)

ON-Stim

EXPERIMENTAL

acoustic stimulation

Device: Dreem headband

OFF-Stim

SHAM COMPARATOR

no acoustic stimulation

Device: Dreem headband

Interventions

Dreem headband DEVICE

acoustic stimulation

ON-Stim

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anna-Chloé BALAGEAS, PhD

CONTACT

0234378952; a.balageas@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 30, 2020
• Study Start: March 11, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

FR (1)