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Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Swiss National Science Foundation
interventional
60
1 country
1
Study Start
February 21, 2025
Actual (reported)Primary Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 29, 2024
Actual (reported)November 1, 2024
Actual (reported)February 21, 2025
Actual (reported)May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Episodic memory performance differences (between and within subject) according to the experimental condition
Episodic memory performance will be assessed by means of serious games.
Participants will play serious games on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.
Electrophysiological Response - Event-Related Potentials (ERPs)
Sleep-Electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.
Electrophysiological Response - Power, Number, and Amplitude of Slow Oscillations (SO) and Spindles
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.
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.
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.
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern
Bern, 3000 60, Switzerland
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.
Marc A Züst, PhD
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
First Submitted
October 29, 2024
First Posted
November 1, 2024
Study Start
February 21, 2025
Actual (reported)Primary Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.
Electrophysiological Response - Coupling of Slow Oscillations and Sleep Spindles
Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.
Amyloid-Beta Response
At baseline, after 4 weeks, after 6 weeks, after 10 weeks
Electrophysiology - Brain Age Estimation
Sleep electrophysiology will be measured on weekdays during the adaptation week and on weekdays throughout both the first and second 4-week intervention periods.
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.
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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.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2026
Record last verified: 2026-04
Currently, there are no collaborations to disclose, but the investigators are generally open to such endeavours in the future. For this purpose, general consent for reuse of data is being collected from participants.
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Source: ClinicalTrials.gov.
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