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Enhancement of Sleep With Wearables (WESA)

2 mars 2021 uppdaterad av: Swiss Federal Institute of Technology

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

33

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 84 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
Enhet: 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
Enhet: No application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sleep quality
Tidsram: 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.
From baseline period to study completion, assessed up to 2 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Daily functioning - Mood
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: 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
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
Tidsram: From baseline period to study completion, assessed up to 2 months
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
Tidsram: Through study completion, approximately 2 months
Physical activity levels will be obtained using wearable monitors
Through study completion, approximately 2 months

Andra resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Swiss Federal Institute of Technology

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 maj 2018

Primärt slutförande (Faktisk)

5 mars 2019

Avslutad studie (Faktisk)

30 oktober 2020

Studieregistreringsdatum

Först inskickad

4 december 2017

Först inskickad som uppfyllde QC-kriterierna

26 januari 2018

Första postat (Faktisk)

5 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • WESA_2017-01436

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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