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Completed

NCT Number: NCT04570761

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tours

Tours, 37044, France

About this study

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

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dreem headband

Device

acoustic stimulation

Primary outcomes

  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.

    Time frame: Day 7

    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.

  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.

    Time frame: Day 8

    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.

  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.

    Time frame: Day 14

    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.

  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.

    Time frame: 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 outcomes

  1. Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.

    Time frame: Day 7

    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.

  2. Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.

    Time frame: Day 8

    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.

  3. Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.

    Time frame: Day 14

    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.

  4. Number of reminders found between the "ON-stimulation" condition and the "OFF-stimulation" condition, on the ecological memory task.

    Time frame: 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.

  5. The memory complaint for Mc Nair's Questionnaire

    Time frame: Baseline

    score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.

  6. Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)

    Time frame: Baseline

    score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.

  7. Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)

    Time frame: Baseline

    score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.

  8. Quality of sleep for Pittsburgh Index (PSQI)

    Time frame: Baseline

    It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.

  9. The memory complaint for Mc Nair's Questionnaire

    Time frame: Day 15

    score from 0 to 156.156 control of a bad score. The variation between J0 and J15 will be studied.

  10. Psychoaffective aspects (Depression) for MADRS (Montgomery Asberg Depression Rating Scale)

    Time frame: Day 15

    score from 0 to 60.60 control of a bad score. The variation between J0 and J15 will be studied.

  11. Psychoaffective aspects (Anxiety) for HAMA (Hamilton Anxiety)

    Time frame: Day 15

    score from 0 to 56.56 control of a bad score. The variation between J0 and J15 will be studied.

  12. Quality of sleep for Pittsburgh Index (PSQI)

    Time frame: Day 15

    It is more an index of tolerance than efficiency. If the score is higher, the tolerance is lower.

  13. amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition

    Time frame: Day 7

    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

  14. amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition

    Time frame: Day 8

    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

  15. amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition

    Time frame: Day 14

    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

  16. amplitude of slow waves in deep slow sleep between the "ON-stimulation" condition and the "OFF-stimulation" condition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: PINK-AD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 30, 2020
Registry last updated
Jun 15, 2026

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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