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Enhancement of Sleep With Wearables (WESA)

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Sleep

Treatments

Device: Application of tones
Device: No application of tones

Study type

Interventional

Funder types

Other

Identifiers

NCT03420677
WESA_2017-01436

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 84 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

33 participants in 2 patient groups

Application of tones
Active Comparator group
Description:
During non-rapid eye movement (NREM) sleep short tones will be played
Treatment:
Device: Application of tones
No application of tones
Sham Comparator group
Description:
During NREM sleep no short tones will be played
Treatment:
Device: No application of tones

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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