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Clinical Trials/NCT04277104
NCT04277104
Completed
Not Applicable

Improving Slow Wave Sleep by Auditory Stimulation to Enhance Memory Consolidation and New Learning in Healthy Older Adults and Older Individuals at Risk for Dementia

University of Bern1 site in 1 country47 target enrollmentOctober 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Bern
Enrollment
47
Locations
1
Primary Endpoint
Change from baseline episodic memory performance after three nights of intervention
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2019
End Date
July 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change from baseline episodic memory performance after three nights of intervention

Time Frame: 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

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)

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

Time Frame: 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.

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)

Secondary Outcomes

  • Improvements in sleep physiology(Three consecutive nights of EEG measurement/polysomnography)
  • 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))
  • Improvement in episodic memory performance at follow-ups(One week as well as 3 months after intervention)

Study Sites (1)

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