Enhancement of Sleep With Wearables

NCT ID: NCT03420677

Last Updated: 2021-03-03

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2020-10-30

Brief Summary

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Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.

Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Application of tones

During non-rapid eye movement (NREM) sleep short tones will be played

Group Type ACTIVE_COMPARATOR

Application of tones

Intervention Type DEVICE

During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic

No application of tones

During NREM sleep no short tones will be played

Group Type SHAM_COMPARATOR

No application of tones

Intervention Type DEVICE

This is the sham-control intervention; The device will only record biosignals but will not play tones.

Interventions

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Application of tones

During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic

Intervention Type DEVICE

No application of tones

This is the sham-control intervention; The device will only record biosignals but will not play tones.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Informed Consent as documented by signature
* For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago
* Good general health status
* Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
* Male and Female subjects 18-35 years of age or 60-84 years of age
* German speaking

Exclusion Criteria

* Women who are pregnant or breast feeding,
* Known or suspected non-compliance, drug or alcohol abuse,
* Intake of sleep altering medication
* Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS),
* Diagnosed internal disease,
* Presence of sleep disorders,
* Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn)
* Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly)
* Hearing disability/ hearing aid
* Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application
* Nicotine/Cannabis use
* High caffeine consumption (\> 5 servings/day; including coffee, energy drink)
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Federal Institute of Technology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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Lustenberger C, Ferster ML, Huwiler S, Brogli L, Werth E, Huber R, Karlen W. Auditory deep sleep stimulation in older adults at home: a randomized crossover trial. Commun Med (Lond). 2022 Apr 4;2:30. doi: 10.1038/s43856-022-00096-6. eCollection 2022.

Reference Type DERIVED
PMID: 35603302 (View on PubMed)

Other Identifiers

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WESA_2017-01436

Identifier Type: -

Identifier Source: org_study_id

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