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

NCT ID: NCT04277104

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2023-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy intervention

Acoustic stimulation

Group Type EXPERIMENTAL

Closed loop acoustic stimulation

Intervention Type 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

Healthy sham

No stimulation

Group Type SHAM_COMPARATOR

Sham acoustic stimulation

Intervention Type 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 intervention

Acoustic stimulation

Group Type EXPERIMENTAL

Closed loop acoustic stimulation

Intervention Type 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 sham

No stimulation

Group Type SHAM_COMPARATOR

Sham acoustic stimulation

Intervention Type 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.

MCI (mild cognitive impairment) intervention

Acoustic stimulation

Group Type EXPERIMENTAL

Closed loop acoustic stimulation

Intervention Type 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

MCI (mild cognitive impairment) sham

No stimulation

Group Type SHAM_COMPARATOR

Sham acoustic stimulation

Intervention Type 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.

Interventions

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Closed loop acoustic stimulation

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

Intervention Type OTHER

Sham acoustic stimulation

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Klöppel, Prof.

Role: PRINCIPAL_INVESTIGATOR

University hospital of old age psychiatry and psychotherapy

Locations

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University Hospital of Old Age Psychiatry and Psychotherapy

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 38744792 (View on PubMed)

Other Identifiers

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2018-01979

Identifier Type: -

Identifier Source: org_study_id