Enhancement of Sleep With Wearables

NCT03420677 | Completed DMC

• 1 other identifier: WESA_2017-01436
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Daily functioning - Mood

  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

  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

  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

  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

  From baseline period to study completion, assessed up to 2 months

Other Outcomes (10)

• Device usability

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

• Diary

  Through study completion, approximately 2 months

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

  Through study completion, approximately 2 months

Study Arms (2)

Application of tones

ACTIVE COMPARATOR

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

Device: Application of tones

No application of tones

SHAM COMPARATOR

During NREM sleep no short tones will be played

Device: No application of tones

Interventions

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

Application of tones

No application of tones DEVICE

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

No application of tones

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

Swiss Federal Institute of Technology

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35603302 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: February 5, 2018
• Study Start: May 7, 2018
• Primary Completion: March 5, 2019
• Study Completion: October 30, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

CH (1)