NCT06669546Recruiting
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
Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 21 Feb 2025
- Primary completion date
- May 2028
- Lead sponsor
- University of Bern
- Diseases
- Alzheimer disease
- NCT number
- NCT06669546
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 21 Feb 2025 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medication acting on the central nervous system
Other illness
- Restless leg syndrome assessed by questions concerning typical symptoms.
- History of untreated severe neurological and psychiatric diseases
Other
- Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)
- 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)
- Alcohol or substance abuse
Who the study is looking for
- 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.
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.