Auditory deep sleep stimulation in older adults at home: a randomized crossover trial.
Caroline Lustenberger, M Laura Ferster, Stephanie Huwiler...
https://pubmed.ncbi.nlm.nih.gov/35603302Actively Recruiting
Phase Not Applicable
Age: 60Years - 85Years
All Genders
ID06669546
Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement with Phase-Locked Auditory Stimulation in Older Adults with Mild Memory Impairment
Led by University of Bern · Updated on 2026-04-03
60
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a non-invasive method to improve memory and slow cognitive decline in older adults by enhancing the quality of deep, slow-wave sleep (SWS). Dementia, a leading cause of death worldwide, is linked to disturbed sleep, especially the loss of SWS, which plays a key role in memory and clearing waste from the brain. Poor SWS may worsen memory loss and increase dementia risk. This study focuses on people with mild cognitive impairment and aims to test if phase-locked auditory stimulation (PLAS) can improve SWS and related brain functions. The study involves 60 older adults using a home-use SleepLoop device that delivers either real or sham (soundless) PLAS during sleep. Participants undergo two 4-week intervention periods separated by a 2-week washout phase. One group receives real PLAS first followed by sham stimulation, and the other group receives sham first then real PLAS. The device detects slow oscillations in sleep and delivers short sound stimuli during deep sleep to strengthen slow-wave brain activity. The stimulation is applied on weeknights, Monday to Friday, and is individually calibrated for each participant. Participants will play memory-testing serious games on weekdays during an adaptation week and throughout both intervention periods. Blood samples will be collected at baseline and after 4, 6, and 10 weeks to measure dementia-related markers. Sleep electrophysiology and cognitive tests will be performed regularly to assess changes. Researchers will monitor memory performance, brain activity during sleep, and blood biomarkers to evaluate the effects of PLAS. The total study duration includes adaptation, intervention, washout, and follow-up periods, extending up to 10 weeks for each participant.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 60Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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) to support use of study materials/devices
You will not qualify if you...
- Insomnia assessed by the Regensburg Insomnia Scale
- Restless leg syndrome based on typical symptoms
- Sleep apnoea assessed by the Berlin Questionnaire
- Severely irregular sleep patterns assessed by the Regensburg Insomnia Scale and Pittsburgh Sleep Quality Index
- Symptoms of depression (Geriatric Depression Scale score ≥ 5)
- History of untreated severe neurological and psychiatric diseases
- Alcohol or substance abuse
- Use of medication acting on the central nervous system
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Run-in Period
Duration - 1 week
Participants undergo an adaptation week with sleep-electrophysiology measurements and serious game practice on weekdays to prepare for the intervention periods.
Weekday visits for adaptation measurements and training
Treatment
Duration - 4 weeks
Participants receive 4 weeks of phase-locked auditory stimulation (PLAS) or sham stimulation on weeknights (Monday to Friday) using the SleepLoop device during deep sleep to study effects on brain activity and memory.
Weekday usage from Monday to Friday during intervention
Washout Period
Duration - 2 weeks
Participants have a 2-week break without stimulation between the two intervention periods to wash out effects of the first treatment.
No visits required during washout
Treatment
Duration - 4 weeks
Participants receive the alternate 4-week phase-locked auditory stimulation (PLAS) or sham stimulation on weeknights (Monday to Friday) using the SleepLoop device during deep sleep.
Weekday usage from Monday to Friday during intervention
Follow-up
Duration - 10 weeks total from baseline through last assessment
Participants are assessed for memory performance, brain activity, and blood biomarkers at baseline, after 4 weeks, after 6 weeks, and after 10 weeks to evaluate the effects of the interventions.
Assessments at baseline, 4 weeks, 6 weeks, and 10 weeks
Trial Site Locations
Total: 1 location
1
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern
Bern, Switzerland, 3000 60
Actively Recruiting
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Research Team
M
Marc A Züst, PhD
K
Korian Wicki, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Modulating overnight memory consolidation by acoustic stimulation during slow-wave sleep: a systematic review and meta-analysis.
Marina Wunderlin, Marc A Züst, Elisabeth Hertenstein...
https://pubmed.ncbi.nlm.nih.gov/33406249Multi-night acoustic stimulation is associated with better sleep, amyloid dynamics, and memory in older adults with cognitive impairment.
Céline J Zeller, Marina Wunderlin, Korian Wicki...
https://pubmed.ncbi.nlm.nih.gov/38744792Acoustic stimulation during sleep predicts long-lasting increases in memory performance and beneficial amyloid response in older adults.
Marina Wunderlin, Céline Jacqueline Zeller, Samira Rafaela Senti...
https://pubmed.ncbi.nlm.nih.gov/38163288