NCT07529015 · NOT YET RECRUITING

Acoustic Stimulation During Sleep: Effects on Memory and p-tau217 in MCI

This trial tests whether gentle sounds timed to your brain waves during sleep can deepen slow-wave sleep, improve memory, and shift a blood marker linked to Alzheimer's called p-tau217. Participants have MCI (mild memory problems) or are cognitively healthy. Phase is not applicable because it is a device study, so this is early research, not proven.

You may qualify if

  • Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and positive state of plasma p-tau217.
  • Diagnosis of aMCI according to the NIA-AA criteria (Albert et al., 2011) and negative state of plasma p-tau217 for aMCI negative group.
  • Cognitively unimpaired older subjects aged ≥ 65 years, Mini-mental state examination ≥28, and negative for plasma p-tau217.

You're excluded if

  • Diagnosis of dementia due to AD or any other type of dementia.
  • Presence of any diagnosed sleep disorder such as narcolepsy, severe insomnia, severe obstructive sleep apnea, or severe chronic lack of sleep.
  • Hearing problems.
  • Analphabet individuals.
  • Comorbidities such as cancer, severe depression, severe renal or hepatic insufficiency, history of seizures, and severe cardiac or respiratory failure.
  • Alcohol and substance abuse.
  • Magnetic resonance imaging (MRI) evidence of stroke, hydrocephalus, a space-occupying lesion, or any clinically relevant central nervous system disease.
  • Existence of untreated (or treated for less than 3 months prior to the screening visit) vitamin B12 or folate deficiency.
  • Presence of untreated thyroid disease.
  • Use of betablockers, antidepressants, neuroleptics, and hypnotics, within 15 days before conducting polysomnography.

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 2026-04-14

View full record on ClinicalTrials.gov

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