Clinical trial NCT04570761: Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Official title: Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer's Disease (AD)
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Day 7
measure: 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.
timeFrame: Day 8
measure: 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.
timeFrame: Day 14
measure: 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.
timeFrame: Day 15
Secondary outcomes:
measure: Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
timeFrame: Day 7
measure: Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
timeFrame: Day 8
measure: Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
timeFrame: Day 14
measure: Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.
timeFrame: Day 15
measure: The memory complaint for Mc Nair's Questionnaire
timeFrame: Baseline
measure: Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
timeFrame: Baseline
measure: Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
timeFrame: Baseline
measure: Quality of sleep for Pittsburgh Index (PSQI)
timeFrame: Baseline
measure: The memory complaint for Mc Nair's Questionnaire
timeFrame: Day 15
measure: Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)
timeFrame: Day 15
measure: Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)
timeFrame: Day 15
measure: Quality of sleep for Pittsburgh Index (PSQI)
timeFrame: Day 15
measure: amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
timeFrame: Day 7
measure: amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
timeFrame: Day 8
measure: amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
timeFrame: Day 14
measure: amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition
timeFrame: Day 15
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
References: