- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03420677
Enhancement of Sleep With Wearables (WESA)
2. mars 2021 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
33
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Zurich
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Zürich, Zurich, Sveits, 8092
- Swiss Federal Institute of Technology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 84 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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-komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Sleep quality
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Daily functioning - Mood
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Device usability
Tidsramme: 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
Tidsramme: 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]
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. mai 2018
Primær fullføring (Faktiske)
5. mars 2019
Studiet fullført (Faktiske)
30. oktober 2020
Datoer for studieregistrering
Først innsendt
4. desember 2017
Først innsendt som oppfylte QC-kriteriene
26. januar 2018
Først lagt ut (Faktiske)
5. februar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mars 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. mars 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- WESA_2017-01436
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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