Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment
NCT ID: NCT06669546
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-02-21
2028-12-31
Brief Summary
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The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting.
In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline.
If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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PLAS first, sham second
In this study arm, participants will undergo a 4-week intervention period with real phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which sham (soundless) PLAS will be administered.
Phase-locked auditory stimulation (PLAS)
Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device.
The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink noise) during the positive half-waves of slow waves in slow-wave sleep (SWS). These stimuli are delivered through integrated headphones in the SleepLoop device. The intervention is applied during work days for 4 weeks. The algorithm is only active during SWS and does not deliver stimuli when the participant is awake, or in lighter sleep stages (N1, N2) or REM sleep. The intensity and algorithm sensitivity are individually calibrated for each participant to optimize stimulation.
Sham Phase-Locked Auditory Stimulation
Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.
Sham first, PLAS second
In this study arm, participants will undergo a 4-week intervention period with sham (soundless) phase-locked auditory stimulation (PLAS) administered on nights from Monday to Friday. Following this initial intervention period, participants will have a 2-week washout phase. Finally, participants will enter the second intervention period, during which real PLAS will be administered.
Phase-locked auditory stimulation (PLAS)
Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device.
The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink noise) during the positive half-waves of slow waves in slow-wave sleep (SWS). These stimuli are delivered through integrated headphones in the SleepLoop device. The intervention is applied during work days for 4 weeks. The algorithm is only active during SWS and does not deliver stimuli when the participant is awake, or in lighter sleep stages (N1, N2) or REM sleep. The intensity and algorithm sensitivity are individually calibrated for each participant to optimize stimulation.
Sham Phase-Locked Auditory Stimulation
Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.
Interventions
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Phase-locked auditory stimulation (PLAS)
Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device.
The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink noise) during the positive half-waves of slow waves in slow-wave sleep (SWS). These stimuli are delivered through integrated headphones in the SleepLoop device. The intervention is applied during work days for 4 weeks. The algorithm is only active during SWS and does not deliver stimuli when the participant is awake, or in lighter sleep stages (N1, N2) or REM sleep. The intensity and algorithm sensitivity are individually calibrated for each participant to optimize stimulation.
Sham Phase-Locked Auditory Stimulation
Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 60 and 85 years
* Cognitive impairment (subjective and/or MoCA between 23-26)
* Native German speakers or comparably fluent
* Normal or corrected-to-normal vision.
* Intact hearing
* A close cohabitant (partner/sibling) should be present to support participants in using study materials/devices.
Exclusion Criteria
* Restless leg syndrome assessed by questions concerning typical symptoms.
* Sleep apnoea assessed by the Berlin Questionnaire (BQ; Netzer et al., 1999)
* Severely irregular sleep patterns assessed by the RIS and the Pittsburgh sleep quality index (PSQI; Buysse et al., 1989)
* Symptoms of depression (Geriatric Depression Scale (GDS; Yesavage et al., 1982) ≥ 5)
* History of untreated severe neurological and psychiatric diseases
* Alcohol or substance abuse
* Use of medication acting on the central nervous system
60 Years
85 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
OTHER
University of Bern
OTHER
Responsible Party
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Principal Investigators
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Marc A Züst, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
Locations
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University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Lustenberger C, Ferster ML, Huwiler S, Brogli L, Werth E, Huber R, Karlen W. Auditory deep sleep stimulation in older adults at home: a randomized crossover trial. Commun Med (Lond). 2022 Apr 4;2:30. doi: 10.1038/s43856-022-00096-6. eCollection 2022.
Wunderlin M, Zust MA, Hertenstein E, Feher KD, Schneider CL, Kloppel S, Nissen C. Modulating overnight memory consolidation by acoustic stimulation during slow-wave sleep: a systematic review and meta-analysis. Sleep. 2021 Jul 9;44(7):zsaa296. doi: 10.1093/sleep/zsaa296.
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.
Wunderlin M, Zeller CJ, Senti SR, Feher KD, Suppiger D, Wyss P, Koenig T, Teunissen CE, Nissen C, Kloppel S, Zust MA. Acoustic stimulation during sleep predicts long-lasting increases in memory performance and beneficial amyloid response in older adults. Age Ageing. 2023 Dec 1;52(12):afad228. doi: 10.1093/ageing/afad228.
Related Links
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Information on current sleep studies at the Memory Clinic Bern, focused on research related to sleep and cognitive function.
Other Identifiers
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215333
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-00409
Identifier Type: -
Identifier Source: org_study_id
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