Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?
Primary Purpose
Healthy, Mild Cognitive Impairment, Alzheimer Disease
Status
Active
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Closed loop acoustic stimulation
Sham acoustic stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Fluent in German
- Normal or corrected to normal vision
- Unimpaired hearing
- For healthy group: Montreal Cognitive Assessment Score ≥ 26
- For MCI group: Montreal Cognitive Assessment Score < 26
- For at risk group: smoker, high cholesterol, high blood pressure and high fasting plasma glucose OR smoker, high BMI, physically inactive, unhealthy dietary habits
Exclusion Criteria:
- Known sleep problems such as Insomnia, restless leg syndrome, apnea
- Irregular sleep pattern
- Symptoms of depression
- History of untreated severe neurological and psychiatric diseases
- Alcohol or substance abuse
- Use of medication acting on the central nervous system
Sites / Locations
- University Hospital of Old Age Psychiatry and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Sham Comparator
Experimental
Sham Comparator
Experimental
Sham Comparator
Arm Label
Healthy intervention
Healthy sham
At risk intervention
At risk sham
MCI (mild cognitive impairment) intervention
MCI (mild cognitive impairment) sham
Arm Description
Acoustic stimulation
No stimulation
Acoustic stimulation
No stimulation
Acoustic stimulation
No stimulation
Outcomes
Primary Outcome Measures
Change from baseline episodic memory performance after three nights of intervention
Face-occupation associative memory task: encoding of 40 faces coupled with 40 occupations takes place on the evening of the first intervention night followed by a retrieval session (BASELINE). Feedback-based retrieval sessions take place on the following mornings and evenings of three consecutive intervention nights (4 feedback-based encoding sessions). After the last intervention night a retrieval session without feedback is performed upon waking (ASSESSMENT OF CHANGE)
Change from baseline performance in computer-based verbal new learning task (episodic memory) after three nights of intervention
Verbal associative memory task: a list of 30 moderately associated word pairs (e.g. balloon-air) are presented on a screen. The respective word pairs are displayed for five seconds each and participants are asked to memorize them. After a one-minute break, a cued recall follows in which one word of each pair is randomly shown and participants are prompted to name the matching second word (BASELINE). After the last intervention night a different list of 30 word pairs is used for another session of encoding and retrieval (ASSESSMENT OF CHANGE)
Secondary Outcome Measures
Improvements in sleep physiology
EEG-data: Quality of slow wave sleep, number of slow oscillations, number of sleep spindles can all be measured by the data provided by the electroencephalographic recordings. A high densitiy electrode cap with 128 channels is used for this purpose.
Improvement in episodic memory performance at follow-ups
Face-occupation associative memory task
Improvement in new learning of episodic memory at follow-ups
Verbal associative memory task
Decreases in plasma amyloid-beta
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04277104
Brief Title
Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?
Official Title
Improving Slow Wave Sleep by Auditory Stimulation to Enhance Memory Consolidation and New Learning in Healthy Older Adults and Older Individuals at Risk for Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 20, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
With aging the amount of slow wave sleep decreases drastically and this disruption is markedly exaggerated in older adults suffering from mild cognitive impairment and Alzheimer's disease. Critically, the disruption of slow wave sleep and cognitive decline seem bidirectionally linked forming a vicious cycle. In the long run, improving slow wave sleep might be a useful intervention tool to delay the onset of cognitive decline. The present study aims at improving slow wave sleep and memory functions through a closed-loop acoustic stimulation approach. A closed-loop algorithm is used that detects slow waves in the electroencephalogram and is programmed to present short tones (50 ms) in the rhythm of these waves. This procedure has shown to boost both slow wave sleep as well as memory performance, mainly in young adults and when applied for one night. Here, the investigators apply tones via multiple consecutive nights and assess memory performance during this 3-night intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Mild Cognitive Impairment, Alzheimer Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy intervention
Arm Type
Experimental
Arm Description
Acoustic stimulation
Arm Title
Healthy sham
Arm Type
Sham Comparator
Arm Description
No stimulation
Arm Title
At risk intervention
Arm Type
Experimental
Arm Description
Acoustic stimulation
Arm Title
At risk sham
Arm Type
Sham Comparator
Arm Description
No stimulation
Arm Title
MCI (mild cognitive impairment) intervention
Arm Type
Experimental
Arm Description
Acoustic stimulation
Arm Title
MCI (mild cognitive impairment) sham
Arm Type
Sham Comparator
Arm Description
No stimulation
Intervention Type
Other
Intervention Name(s)
Closed loop acoustic stimulation
Intervention Description
The intervention consists of three consecutive nights of closed loop acoustic stimulation during slow wave sleep. An established closed-loop algorithm is utilized that detects slow oscillations in the electroencephalogram and is programmed to present short tones (50 ms) into their up-states. Tones will be presented via a headband with integrated speakers. The procedure does not wake participants
Intervention Type
Other
Intervention Name(s)
Sham acoustic stimulation
Intervention Description
Sham acoustic stimulation: participants wear the headband but no stimuli are delivered during slow wave sleep. This ensures that in both the control and the intervention group the conscious experiences are the same.
Primary Outcome Measure Information:
Title
Change from baseline episodic memory performance after three nights of intervention
Description
Face-occupation associative memory task: encoding of 40 faces coupled with 40 occupations takes place on the evening of the first intervention night followed by a retrieval session (BASELINE). Feedback-based retrieval sessions take place on the following mornings and evenings of three consecutive intervention nights (4 feedback-based encoding sessions). After the last intervention night a retrieval session without feedback is performed upon waking (ASSESSMENT OF CHANGE)
Time Frame
The change in memory performance will be assessed between the baseline measurement (evening before the first intervention night) and on the morning of the last intervention night (1 hour after waking), 3 days after initial encoding
Title
Change from baseline performance in computer-based verbal new learning task (episodic memory) after three nights of intervention
Description
Verbal associative memory task: a list of 30 moderately associated word pairs (e.g. balloon-air) are presented on a screen. The respective word pairs are displayed for five seconds each and participants are asked to memorize them. After a one-minute break, a cued recall follows in which one word of each pair is randomly shown and participants are prompted to name the matching second word (BASELINE). After the last intervention night a different list of 30 word pairs is used for another session of encoding and retrieval (ASSESSMENT OF CHANGE)
Time Frame
The change in new learning performance will be assessed between the baseline measurement (morning before the first intervention night) and on the morning of the last intervention night (1.5 hour after waking), 3 days after.
Secondary Outcome Measure Information:
Title
Improvements in sleep physiology
Description
EEG-data: Quality of slow wave sleep, number of slow oscillations, number of sleep spindles can all be measured by the data provided by the electroencephalographic recordings. A high densitiy electrode cap with 128 channels is used for this purpose.
Time Frame
Three consecutive nights of EEG measurement/polysomnography
Title
Improvement in episodic memory performance at follow-ups
Description
Face-occupation associative memory task
Time Frame
One week as well as 3 months after intervention
Title
Improvement in new learning of episodic memory at follow-ups
Description
Verbal associative memory task
Time Frame
One week as well as 3 months after intervention
Title
Decreases in plasma amyloid-beta
Time Frame
Blood samples will be taken twice: on the morning before the first intervention night, on the morning after the last intervention night (3 days apart)
Other Pre-specified Outcome Measures:
Title
General cognitive functions: working memory
Description
A computer based visual n-back task is performed (established task for working memory)
Time Frame
Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention
Title
General cognitive functions: cognitive flexibility
Description
A computer based task switch task is performed (established task for cognitive flexibility)
Time Frame
Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention
Title
General cognitive functions: cognitive inhibition
Description
A computer based go/no go task is performed (established task for cognitive inhibition)
Time Frame
Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Fluent in German
Normal or corrected to normal vision
Unimpaired hearing
For healthy group: Montreal Cognitive Assessment Score ≥ 26
For MCI group: Montreal Cognitive Assessment Score < 26
For at risk group: smoker, high cholesterol, high blood pressure and high fasting plasma glucose OR smoker, high BMI, physically inactive, unhealthy dietary habits
Exclusion Criteria:
Known sleep problems such as Insomnia, restless leg syndrome, apnea
Irregular sleep pattern
Symptoms of depression
History of untreated severe neurological and psychiatric diseases
Alcohol or substance abuse
Use of medication acting on the central nervous system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Klöppel, Prof.
Organizational Affiliation
University hospital of old age psychiatry and psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Old Age Psychiatry and Psychotherapy
City
Bern
ZIP/Postal Code
3000 60
Country
Switzerland
12. IPD Sharing Statement
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