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

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 21, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

December 31, 2028

Conditions
Cognitive DeclineAlzheimer DiseaseSubjective Cognitive Decline (SCD)Mild Cognitive Impairment (MCI)Cognitive Impairment, Mild
Interventions
OTHER

Phase-locked auditory stimulation (PLAS)

"Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device.~The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink noise) during the positive half-waves of slow waves in slow-wave sleep (SWS). These stimuli are delivered through integrated headphones in the SleepLoop device. The intervention is applied during work days for 4 weeks. The algorithm is only active during SWS and does not deliver stimuli when the participant is awake, or in lighter sleep stages (N1, N2) or REM sleep. The intensity and algorithm sensitivity are individually calibrated for each participant to optimize stimulation."

OTHER

Sham Phase-Locked Auditory Stimulation

Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.

Trial Locations (1)

3000 60

RECRUITING

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

All Listed Sponsors
collaborator

University of Zurich

OTHER

collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

OTHER

lead

University of Bern

OTHER