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Completed

NCT Number: NCT03420677

Enhancement of Sleep With Wearables

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.

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Key information

Conditions

Sleep

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Federal Institute of Technology

Zurich, Canton of Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Application of tones

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

Device

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

Primary outcomes

  1. Sleep quality

    Time frame: From baseline period to study completion, assessed up to 2 months

    Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham.

Secondary outcomes

  1. Daily functioning - Mood

    Time frame: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks

    Mood will be digitally assessed using a daily mood scale over the intervention period

  2. Daily functioning - Quality of life

    Time frame: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks

    Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period

  3. Daily functioning - Vigilance

    Time frame: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks

    Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period

  4. Daily functioning - Cognition

    Time frame: From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks

    Cognition will be assessed using a digital test battery before and after each intervention

  5. Physiological parameters - Cardiovascular

    Time frame: From baseline period to study completion, assessed up to 2 months

    R-R interval based assessments will be obtained using wearable monitors

  6. Physiological parameters - Physical activity

    Time frame: Through study completion, approximately 2 months

    Physical activity levels will be obtained using wearable monitors

Other outcomes

  1. Device usability

    Time frame: From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months

    Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition

  2. Diary

    Time frame: Through study completion, approximately 2 months

    Information about daily habits will be digitally assessed

  3. Incidence of Intervention-related Adverse Events [Safety and Tolerability]

    Time frame: Through study completion, approximately 2 months

    Any adverse or serious adverse events during the study period will be assessed

  4. Chronotype

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of circadian type

  5. Handedness

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of handedness

  6. Menstrual cycle

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of menstrual cycle information in woman

  7. Height

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of height

  8. Hip-to-waist ratio

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of hip and waist circumference

  9. Blood pressure

    Time frame: Through study completion, approximately 2 months

    Assessment of blood pressure

  10. Weight

    Time frame: Before start of intervention period (single-time assessment during one initial 1-day visit)

    Assessment of weight

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Enhancement of Sleep Slow Wave Activity Using Wearable Auditory Stimulation Devices and Its Consequences on Daytime Functioning: a Randomized, Counter-balanced Crossover Study

Acronym: WESA

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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