Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?

NCT04277104 | Completed DMC

• 1 other identifier: 2018-01979
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

With aging the amount of slow wave sleep decreases drastically and this disruption is markedly exaggerated in older adults suffering from mild cognitive impairment and Alzheimer's disease. Critically, the disruption of slow wave sleep and cognitive decline seem bidirectionally linked forming a vicious cycle. In the long run, improving slow wave sleep might be a useful intervention tool to delay the onset of cognitive decline. The present study aims at improving slow wave sleep and memory functions through a closed-loop acoustic stimulation approach. A closed-loop algorithm is used that detects slow waves in the electroencephalogram and is programmed to present short tones (50 ms) in the rhythm of these waves. This procedure has shown to boost both slow wave sleep as well as memory performance, mainly in young adults and when applied for one night. Here, the investigators apply tones via multiple consecutive nights and assess memory performance during this 3-night intervention.

Conditions

Healthy; Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline episodic memory performance after three nights of intervention

  Face-occupation associative memory task: encoding of 40 faces coupled with 40 occupations takes place on the evening of the first intervention night followed by a retrieval session (BASELINE). Feedback-based retrieval sessions take place on the following mornings and evenings of three consecutive intervention nights (4 feedback-based encoding sessions). After the last intervention night a retrieval session without feedback is performed upon waking (ASSESSMENT OF CHANGE)

  The change in memory performance will be assessed between the baseline measurement (evening before the first intervention night) and on the morning of the last intervention night (1 hour after waking), 3 days after initial encoding

• Change from baseline performance in computer-based verbal new learning task (episodic memory) after three nights of intervention

  Verbal associative memory task: a list of 30 moderately associated word pairs (e.g. balloon-air) are presented on a screen. The respective word pairs are displayed for five seconds each and participants are asked to memorize them. After a one-minute break, a cued recall follows in which one word of each pair is randomly shown and participants are prompted to name the matching second word (BASELINE). After the last intervention night a different list of 30 word pairs is used for another session of encoding and retrieval (ASSESSMENT OF CHANGE)

  The change in new learning performance will be assessed between the baseline measurement (morning before the first intervention night) and on the morning of the last intervention night (1.5 hour after waking), 3 days after.

Secondary Outcomes (4)

• Improvements in sleep physiology

  Three consecutive nights of EEG measurement/polysomnography

• Improvement in episodic memory performance at follow-ups

  One week as well as 3 months after intervention

• Improvement in new learning of episodic memory at follow-ups

  One week as well as 3 months after intervention

• Decreases in plasma amyloid-beta

  Blood samples will be taken twice: on the morning before the first intervention night, on the morning after the last intervention night (3 days apart)

Other Outcomes (3)

• General cognitive functions: working memory

  Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention

• General cognitive functions: cognitive flexibility

  Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention

• General cognitive functions: cognitive inhibition

  Assessed four times: on the morning before the first intervention night, on the morning after the last intervention night, one week after and 3 months after the intervention

Study Arms (6)

Healthy intervention

EXPERIMENTAL

Acoustic stimulation

Other: Closed loop acoustic stimulation

Healthy sham

SHAM COMPARATOR

No stimulation

Other: Sham acoustic stimulation

At risk intervention

EXPERIMENTAL

Acoustic stimulation

Other: Closed loop acoustic stimulation

At risk sham

SHAM COMPARATOR

No stimulation

Other: Sham acoustic stimulation

MCI (mild cognitive impairment) intervention

EXPERIMENTAL

Acoustic stimulation

Other: Closed loop acoustic stimulation

MCI (mild cognitive impairment) sham

SHAM COMPARATOR

No stimulation

Other: Sham acoustic stimulation

Interventions

Closed loop acoustic stimulation OTHER

The intervention consists of three consecutive nights of closed loop acoustic stimulation during slow wave sleep. An established closed-loop algorithm is utilized that detects slow oscillations in the electroencephalogram and is programmed to present short tones (50 ms) into their up-states. Tones will be presented via a headband with integrated speakers. The procedure does not wake participants

At risk intervention; Healthy intervention; MCI (mild cognitive impairment) intervention

Sham acoustic stimulation OTHER

Sham acoustic stimulation: participants wear the headband but no stimuli are delivered during slow wave sleep. This ensures that in both the control and the intervention group the conscious experiences are the same.

At risk sham; Healthy sham; MCI (mild cognitive impairment) sham

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Fluent in German
• Normal or corrected to normal vision
• Unimpaired hearing
• For healthy group: Montreal Cognitive Assessment Score ≥ 26
• For MCI group: Montreal Cognitive Assessment Score \< 26
• For at risk group: smoker, high cholesterol, high blood pressure and high fasting plasma glucose OR smoker, high BMI, physically inactive, unhealthy dietary habits

You may not qualify if:

• Known sleep problems such as Insomnia, restless leg syndrome, apnea
• Irregular sleep pattern
• Symptoms of depression
• History of untreated severe neurological and psychiatric diseases
• Alcohol or substance abuse
• Use of medication acting on the central nervous system

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Old Age Psychiatry and Psychotherapy

Bern, 3000 60, Switzerland

Location

Related Publications (1)

• Zeller CJ, Wunderlin M, Wicki K, Teunissen CE, Nissen C, Zust MA, Kloppel S. Multi-night acoustic stimulation is associated with better sleep, amyloid dynamics, and memory in older adults with cognitive impairment. Geroscience. 2024 Dec;46(6):6157-6172. doi: 10.1007/s11357-024-01195-z. Epub 2024 May 14.

  PMID: 38744792 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Stefan Klöppel, Prof.

  University hospital of old age psychiatry and psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: October 20, 2019
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

CH (1)