Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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). 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern
RECRUITING
Bern
Contact Information
Primary
Marc A Züst, PhD
marc.a.zuest@unibe.ch
+41 (0)58 630 95 02
Backup
Korian Wicki, Master
korian.wicki@unibe.ch
+41 76 605 24 00
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Experimental: 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.
Sponsors
Leads: University of Bern
Collaborators: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), University of Zurich

This content was sourced from clinicaltrials.gov

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