Study Results
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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COMPLETED
NA
33 participants
INTERVENTIONAL
2018-05-07
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
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
No application of tones
During NREM sleep no short tones will be played
No application of tones
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
No application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
84 Years
ALL
Yes
Sponsors
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Swiss Federal Institute of Technology
OTHER
Responsible Party
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Locations
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Swiss Federal Institute of Technology
Zurich, Canton of Zurich, Switzerland
Countries
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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.
Other Identifiers
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WESA_2017-01436
Identifier Type: -
Identifier Source: org_study_id
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