Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease… (NCT04570761) | Clinical Trial Compass
CompletedNot Applicable
Effects of Auditory Brain Stimulation by "Pink Noise" on Memory Capacities in Alzheimer's Disease: Proof of Concept Study
France19 participantsStarted 2021-03-11
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used 'pink noise' played during sleep to try to improve memory in people with Alzheimer's — has it published any results yet, and if so, what did they actually find about whether the stimulation made a difference?
2Since this was listed as a 'proof of concept' study with no assigned phase, does that mean the main goal was just to see if the idea is worth pursuing further, rather than to prove it actually works as a treatment?
3The study measured memory by comparing word-matching scores in the morning versus evening during stimulation versus no stimulation — is that kind of short-term memory test meaningful for someone at my stage of Alzheimer's, or does it not capture what matters most to me day-to-day?
4Are there any known risks or downsides to pink noise played during sleep for someone with Alzheimer's, such as effects on sleep quality or agitation, that came up in this or similar studies?
5Given that this trial is already completed, is there a follow-up study recruiting now that uses this approach, or would you recommend focusing on treatments that have more established evidence behind them?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
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.