Do soft sounds played during sleep have an impact on memory?
Descrizione riassuntiva dello studio
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)
Intervento studiato
Acoustic stimulation during deep sleep
(BASEC)
Malattie studiate
Dementia, Alzheimer, memory difficulties
(BASEC)
- Age between 60 and 85 - Mild memory difficulties - Fluent German language skills (BASEC)
Criteri di esclusione
- Severe sleep problems or use of sleep medications - Hearing or uncorrected vision impairment - Mental or neurological disorder - Living alone (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Informazioni generali
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)
Informazioni generali
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)
Informazioni scientifiche
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)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
30.09.2024
(BASEC)
ID di studio ICTRP
NCT06669546 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement (ICTRP)
Titolo pubblico
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)
Malattie studiate
Cognitive DeclineAlzheimer DiseaseSubjective Cognitive Decline (SCD)Mild Cognitive Impairment (MCI)Cognitive Impairment, Mild (ICTRP)
Intervento studiato
Other: Phase-locked auditory stimulation (PLAS)Other: Sham Phase-Locked Auditory Stimulation (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
29.10.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Zurich;Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) (ICTRP)
Contatti aggiuntivi
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)
ID secondari
215333, 2024-00409 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06669546 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile