Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
- Conditions
- Alzheimer's Disease (AD)
- Interventions
- Device: Dreem headband
- Registration Number
- NCT04570761
- Lead Sponsor
- University Hospital, Tours
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description OFF-Stim Dreem headband no acoustic stimulation ON-Stim Dreem headband acoustic stimulation
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition Day 15 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
The memory complaint for Mc Nair's Questionnaire Day 15 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) Day 15 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) Day 15 score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.
Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task. Day 15 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.
Quality of sleep for Pittsburgh Index (PSQI) Day 15 It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.
Trial Locations
- Locations (1)
University Hospital of Tours
🇫🇷Tours, France