NCT06669546 · RECRUITING
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
This study tests whether gentle sounds timed to brain rhythms during deep sleep can improve sleep, memory, and blood markers linked to dementia. Sixty older adults with mild memory concerns use a home device for two 4-week periods, one with real sounds and one silent. Phase is not applicable because this is a device study, not a drug trial. It is not proven.
You may qualify if
- 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.
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-03