Do soft sounds played during sleep have an impact on memory?
Summary description of the study
Healthy sleep is important for health. In this study, we want to test individuals aged 60 to 85 with memory difficulties to find out how improved sleep affects memory and concentration tasks. For this study, participants will be invited to sleep at home for 8 weeks with a portable device, spread over a period of 3 months. This device allows for soft sounds to be played during the night while simultaneously measuring brain activity via electroencephalography (EEG). The sounds played are intended to have a positive impact on deep sleep. Before and after two 4-week intervention phases, blood samples will be taken to investigate metabolic products. At these times, participants will also solve cognitive tasks on-site at the University Clinic for Geriatric Psychiatry and Psychotherapy, UPD Bern. During the day, they will be invited to play memory games on a tablet app, which will help us measure memory performance.
(BASEC)
Intervention under investigation
Acoustic stimulation during deep sleep
(BASEC)
Disease under investigation
Dementia, Alzheimer, memory difficulties
(BASEC)
- Age between 60 and 85 - Mild memory difficulties - Fluent German language skills (BASEC)
Exclusion criteria
- Severe sleep problems or use of sleep medications - Hearing or uncorrected vision impairment - Mental or neurological disorder - Living alone (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
not available
Contact
General Information
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland,
+41 (0)58 630 95 02;+ 41 (0)58 630 68 77
korian.wicki@clutterunibe.ch(ICTRP)
General Information
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland
+41 (0)58 630 95 02+ 41 (0)58 630 68 77
korian.wicki@clutterunibe.ch(ICTRP)
Scientific Information
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland,
+41 (0)58 630 95 02;+ 41 (0)58 630 68 77
korian.wicki@clutterunibe.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
30.09.2024
(BASEC)
ICTRP Trial ID
NCT06669546 (ICTRP)
Official title (approved by ethics committee)
not available
Academic title
Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement (ICTRP)
Public title
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 (ICTRP)
Disease under investigation
Cognitive DeclineAlzheimer DiseaseSubjective Cognitive Decline (SCD)Mild Cognitive Impairment (MCI)Cognitive Impairment, Mild (ICTRP)
Intervention under investigation
Other: Phase-locked auditory stimulation (PLAS)Other: Sham Phase-Locked Auditory Stimulation (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Inclusion/Exclusion 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 Crnlein 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 (ICTRP)
not available
Primary and secondary end points
Episodic memory performance differences (between and within subject) according to the experimental condition (ICTRP)
Electrophysiological Response - Event-Related Potentials (ERPs);Electrophysiological Response - Power, Number, and Amplitude of Slow Oscillations (SO) and Spindles;Electrophysiological Response - Coupling of Slow Oscillations and Sleep Spindles;Amyloid-Beta Response;Electrophysiology - Brain Age Estimation (ICTRP)
Registration date
29.10.2024 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
University of Zurich;Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) (ICTRP)
Additional contacts
Marc A Z?st, PhD;Marc A Z?st, PhD;Korian Wicki, Master, marc.a.zuest@unibe.ch; korian.wicki@unibe.ch, +41 (0)58 630 95 02;+ 41 (0)58 630 68 77, University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, 3000 Bern, Switzerland, (ICTRP)
Secondary trial IDs
215333, 2024-00409 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06669546 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available