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Enhancement of Sleep With Wearables (WESA)
2 maart 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
33
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Zurich
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Zürich, Zurich, Zwitserland, 8092
- Swiss Federal Institute of Technology
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 84 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
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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
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Sham-vergelijker: No application of tones
During NREM sleep no short tones will be played
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This is the sham-control intervention; The device will only record biosignals but will not play tones.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Sleep quality
Tijdsspanne: From baseline period to study completion, assessed up to 2 months
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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.
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From baseline period to study completion, assessed up to 2 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Daily functioning - Mood
Tijdsspanne: 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
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Mood will be digitally assessed using a daily mood scale over the intervention period
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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
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Daily functioning - Quality of life
Tijdsspanne: 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
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Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period
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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
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Daily functioning - Vigilance
Tijdsspanne: 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
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Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period
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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
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Daily functioning - Cognition
Tijdsspanne: 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
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Cognition will be assessed using a digital test battery before and after each intervention
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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
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Physiological parameters - Cardiovascular
Tijdsspanne: From baseline period to study completion, assessed up to 2 months
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R-R interval based assessments will be obtained using wearable monitors
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From baseline period to study completion, assessed up to 2 months
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Physiological parameters - Physical activity
Tijdsspanne: Through study completion, approximately 2 months
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Physical activity levels will be obtained using wearable monitors
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Through study completion, approximately 2 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Device usability
Tijdsspanne: From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
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Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition
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From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
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Diary
Tijdsspanne: Through study completion, approximately 2 months
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Information about daily habits will be digitally assessed
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Through study completion, approximately 2 months
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Incidence of Intervention-related Adverse Events [Safety and Tolerability]
Tijdsspanne: Through study completion, approximately 2 months
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Any adverse or serious adverse events during the study period will be assessed
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Through study completion, approximately 2 months
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Chronotype
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of circadian type
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Handedness
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of handedness
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Menstrual cycle
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of menstrual cycle information in woman
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Height
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of height
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Hip-to-waist ratio
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of hip and waist circumference
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Blood pressure
Tijdsspanne: Through study completion, approximately 2 months
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Assessment of blood pressure
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Through study completion, approximately 2 months
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Weight
Tijdsspanne: Before start of intervention period (single-time assessment during one initial 1-day visit)
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Assessment of weight
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Before start of intervention period (single-time assessment during one initial 1-day visit)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 mei 2018
Primaire voltooiing (Werkelijk)
5 maart 2019
Studie voltooiing (Werkelijk)
30 oktober 2020
Studieregistratiedata
Eerst ingediend
4 december 2017
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2018
Eerst geplaatst (Werkelijk)
5 februari 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 maart 2021
Laatste update ingediend die voldeed aan QC-criteria
2 maart 2021
Laatst geverifieerd
1 maart 2021
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- WESA_2017-01436
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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