Enhancement of Sleep With Wearables (WESA)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Device: Application of tones; Device: No application of tones

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8092
      • Swiss Federal Institute of Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Application of tones; During non-rapid eye movement (NREM) sleep short tones will be played	Device: 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
Sham Comparator: No application of tones; During NREM sleep no short tones will be played	Device: No application of tones; This is the sham-control intervention; The device will only record biosignals but will not play tones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	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.	From baseline period to study completion, assessed up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily functioning - Mood	Mood will be digitally assessed using a daily mood scale over the intervention period	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
Daily functioning - Quality of life	Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period	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
Daily functioning - Vigilance	Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period	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
Daily functioning - Cognition	Cognition will be assessed using a digital test battery before and after each intervention	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
Physiological parameters - Cardiovascular	R-R interval based assessments will be obtained using wearable monitors	From baseline period to study completion, assessed up to 2 months
Physiological parameters - Physical activity	Physical activity levels will be obtained using wearable monitors	Through study completion, approximately 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device usability	Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition	From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
Diary	Information about daily habits will be digitally assessed	Through study completion, approximately 2 months
Incidence of Intervention-related Adverse Events [Safety and Tolerability]	Any adverse or serious adverse events during the study period will be assessed	Through study completion, approximately 2 months
Chronotype	Assessment of circadian type	Before start of intervention period (single-time assessment during one initial 1-day visit)
Handedness	Assessment of handedness	Before start of intervention period (single-time assessment during one initial 1-day visit)
Menstrual cycle	Assessment of menstrual cycle information in woman	Before start of intervention period (single-time assessment during one initial 1-day visit)
Height	Assessment of height	Before start of intervention period (single-time assessment during one initial 1-day visit)
Hip-to-waist ratio	Assessment of hip and waist circumference	Before start of intervention period (single-time assessment during one initial 1-day visit)
Blood pressure	Assessment of blood pressure	Through study completion, approximately 2 months
Weight	Assessment of weight	Before start of intervention period (single-time assessment during one initial 1-day visit)

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: WESA_2017-01436

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No