Cognitive DeclineNCT06669546
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
A study testing Phase-locked auditory stimulation (PLAS) in people with Cognitive Decline and Alzheimer Disease, run by University of Bern at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD)
- What is being tested?
- Phase-locked auditory stimulation (PLAS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Feb 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- 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.
Who cannot join
- Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern
Bern, 3000 60
Korian Wicki, Master, + 41 (0)58 630 68 77, korian.wicki@unibe.ch
Marina Wunderlin, PhD, +41 (0)31 932 87 07, marina.wunderlin@unibe.ch
About this study
Official title: Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
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.
Read more
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.
- Conditions
- Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild
- Being tested
- Phase-locked auditory stimulation (PLAS), Sham Phase-Locked Auditory Stimulation
- Keywords
- Sleep, Dementia, Prevention, Phase-locked auditory stimulation, Blood-based biomarkers, Home, Longitudinal, Electroneurophysiology, EEG, Memory, Cognition, Serious games, Old age, Human
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase-locked auditory stimulation (PLAS)Other
Also called Acoustic stimulation, Phase-targeted auditory stimulation (PTAS), Auditory stimulation, Closed-loop acoustic stimulation
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 StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PLAS first, sham second | Experimental | 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. Receives: Other: Phase-locked auditory stimulation (PLAS); Other: Sham Phase-Locked Auditory Stimulation |
| Sham first, PLAS second | Experimental | 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. Receives: Other: Phase-locked auditory stimulation (PLAS); Other: Sham Phase-Locked Auditory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory performance differences (between and within subject) according to the experimental condition
Episodic memory performance will be assessed by means of serious games.
Measured: 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.
Secondary outcomes (5)
Electrophysiological Response - Event-Related Potentials (ERPs)
Electrophysiological responses will be measured via EEG to assess event-related potentials (ERPs) in response to real versus sham acoustic stimulation.
Measured: 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
Electrophysiological responses will be measured via EEG to assess the power, number, and amplitude of slow oscillations (SO) and sleep spindles in response to real versus sham acoustic stimulation.
Measured: 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
Electrophysiological responses will be measured via EEG to assess the coupling between slow oscillations and spindles in response to real versus sham acoustic stimulation.
Measured: 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
Blood samples will be collected to measure plasma amyloid-beta levels and compare them across conditions.
Measured: At baseline, after 4 weeks, after 6 weeks, after 10 weeks
Electrophysiology - Brain Age Estimation
EEG, EMG, and ECG will be used to estimate brain age and assess whether PLAS leads to a rejuvenation of the brain, reflecting a younger brain state. Machine learning will analyze sleep-EEG data to provide an accurate brain age estimate.
Measured: Sleep electrophysiology will be measured on weekdays during the adaptation week and on weekdays throughout both the first and second 4-week intervention periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start21 Feb 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Responsible party
- Sponsor
- Investigators
- Marc A Züst, PhD, Principal investigator, University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669546
- Sponsor's protocol ID
- 2024-00409
- Other IDs
- 215333
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35603302Wunderlin 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.
PubMed 33406249Zeller 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 38744792Wunderlin 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.
PubMed 38163288
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
- ClinicalTrials.gov ID
- NCT06669546
- Acronym / sponsor ID
- 2024-00409
- Conditions
- Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild
- Keywords
- Sleep, Dementia, Prevention, Phase-locked auditory stimulation, Blood-based biomarkers, Home, Longitudinal, Electroneurophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Zurich, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Nov 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLAS first, sham second | Experimental | Other: Phase-locked auditory stimulation (PLAS), Other: Sham Phase-Locked Auditory StimulationIn 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. |
| Sham first, PLAS second | Experimental | Other: Phase-locked auditory stimulation (PLAS), Other: Sham Phase-Locked Auditory StimulationIn 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent
- 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.
Key exclusion criteria (8 listed)
- Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)
- 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)
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 |
|---|---|---|
| Phase-locked auditory stimulation (PLAS)Also: Acoustic stimulation, Phase-targeted auditory stimulation (PTAS), Auditory stimulation, Closed-loop acoustic stimulationIntervention: 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. | Other | PLAS first, sham second, Sham first, PLAS second |
| Sham Phase-Locked Auditory StimulationParticipants 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 | PLAS first, sham second, Sham first, PLAS second |
Primary outcome
Episodic memory performance differences (between and within subject) according to the experimental condition
Time frame: 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.
Episodic memory performance will be assessed by means of serious games.
5 secondary outcomes
Electrophysiological Response - Event-Related Potentials (ERPs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, after 4 weeks, after 6 weeks, after 10 weeks
Electrophysiology - Brain Age Estimation
Time frame: Sleep electrophysiology will be measured on weekdays during the adaptation week and on weekdays throughout both the first and second 4-week intervention periods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 35603302Lustenberger 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.
- Background: PubMed 33406249Wunderlin 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.
- Background: 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.
- Background: PubMed 38163288Wunderlin 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.
- Information on current sleep studies at the Memory Clinic Bern, focused on research related to sleep and cognitive function.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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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.
Marc A Züst, PhD principal investigator
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase-locked auditory stimulation (PLAS) in people with Cognitive Decline and Alzheimer Disease, 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 8 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc A Züst, PhD (+41 (0)58 630 95 02, marc.a.zuest@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodic memory performance differences (between and within subject) according to the experimental condition (time frame: 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.). 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 NCT06669546, which also lists 4 linked publications.
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 3 Apr 2026.