HealthyNCT04277104
Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?
A study testing Closed loop acoustic stimulation in people with Healthy and Mild Cognitive Impairment, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Closed loop acoustic stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2019to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Old Age Psychiatry and Psychotherapy
Bern, 3000 60
About this study
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
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.
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Closed loop acoustic stimulation, Sham acoustic stimulation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop acoustic stimulationOther
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
Sham acoustic stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy intervention | Experimental | Acoustic stimulation Receives: Other: Closed loop acoustic stimulation |
| Healthy sham | Sham comparator | No stimulation Receives: Other: Sham acoustic stimulation |
| At risk intervention | Experimental | Acoustic stimulation Receives: Other: Closed loop acoustic stimulation |
| At risk sham | Sham comparator | No stimulation Receives: Other: Sham acoustic stimulation |
| MCI (mild cognitive impairment) intervention | Experimental | Acoustic stimulation Receives: Other: Closed loop acoustic stimulation |
| MCI (mild cognitive impairment) sham | Sham comparator | No stimulation Receives: Other: Sham acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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 outcomes (4)
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.
Measured: Three consecutive nights of EEG measurement/polysomnography
Improvement in episodic memory performance at follow-ups
Face-occupation associative memory task
Measured: One week as well as 3 months after intervention
Improvement in new learning of episodic memory at follow-ups
Verbal associative memory task
Measured: One week as well as 3 months after intervention
Decreases in plasma amyloid-beta
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start20 Oct 2019
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Klöppel, Prof., Principal investigator, University hospital of old age psychiatry and psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277104
- Sponsor's protocol ID
- 2018-01979
- Other IDs
- 2018
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2020
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeller CJ, Wunderlin M, Wicki K, Teunissen CE, Nissen C, Zust MA, Kloppel S. Multi-night acoustic stimulation is associated with better sleep, amyloid dynamics, and memory in older adults with cognitive impairment. Geroscience. 2024 Dec;46(6):6157-6172. doi: 10.1007/s11357-024-01195-z. Epub 2024 May 14.
PubMed 38744792
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04277104
- Acronym / sponsor ID
- 2018-01979
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy intervention | Experimental | Other: Closed loop acoustic stimulationAcoustic stimulation |
| Healthy sham | Sham comparator | Other: Sham acoustic stimulationNo stimulation |
| At risk intervention | Experimental | Other: Closed loop acoustic stimulationAcoustic stimulation |
| At risk sham | Sham comparator | Other: Sham acoustic stimulationNo stimulation |
| MCI (mild cognitive impairment) intervention | Experimental | Other: Closed loop acoustic stimulationAcoustic stimulation |
| MCI (mild cognitive impairment) sham | Sham comparator | Other: Sham acoustic stimulationNo stimulation |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- Fluent in German
- Normal or corrected to normal vision
- Unimpaired hearing
- For healthy group: Montreal Cognitive Assessment Score ≥ 26
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed loop acoustic stimulationThe 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 | Other | At risk intervention, Healthy intervention, MCI (mild cognitive impairment) intervention |
| Sham acoustic stimulationSham 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. | Other | At risk sham, Healthy sham, MCI (mild cognitive impairment) sham |
Primary outcome
Change from baseline episodic memory performance after three nights of intervention
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
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
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.
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)
4 secondary outcomes
Improvements in sleep physiology
Time frame: Three consecutive nights of EEG measurement/polysomnography
Improvement in episodic memory performance at follow-ups
Time frame: One week as well as 3 months after intervention
Improvement in new learning of episodic memory at follow-ups
Time frame: One week as well as 3 months after intervention
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 38744792Zeller CJ, Wunderlin M, Wicki K, Teunissen CE, Nissen C, Zust MA, Kloppel S. Multi-night acoustic stimulation is associated with better sleep, amyloid dynamics, and memory in older adults with cognitive impairment. Geroscience. 2024 Dec;46(6):6157-6172. doi: 10.1007/s11357-024-01195-z. Epub 2024 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Klöppel, Prof. principal investigator
University hospital of old age psychiatry and psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop acoustic stimulation in people with Healthy and Mild Cognitive Impairment, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline episodic memory performance after three nights of intervention (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.