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

Last updated: March 25, 2025
Sponsor: University of Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Mild Cognitive Impairment

Alzheimer's Disease

Treatment

Phase-locked auditory stimulation (PLAS)

Sham Phase-Locked Auditory Stimulation

Clinical Study ID

NCT06669546
2024-00409
215333
  • Ages 60-85
  • All Genders

Study 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

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 inusing study materials/devices.

Exclusion

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 sleepquality 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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Phase-locked auditory stimulation (PLAS)
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern

    Bern, 3000 60
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.