NCT06669546 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
| NCT ID | NCT06669546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bern |
| Condition | Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-02-21 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Marc A Züst, PhD
PRINCIPAL INVESTIGATOR
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
Frequently Asked Questions
Who can join the NCT06669546 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06669546 currently recruiting?
Yes, NCT06669546 is actively recruiting participants. Contact the research team at marc.a.zuest@unibe.ch for enrollment information.
Where is the NCT06669546 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06669546 clinical trial?
NCT06669546 is sponsored by University of Bern. The principal investigator is Marc A Züst, PhD at University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland. The trial plans to enroll 60 participants.