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Enhancement of Sleep With Wearables (WESA)

2 marzo 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

33

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 84 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
Dispositivo: 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
Comparatore fittizio: No application of tones
During NREM sleep no short tones will be played
Dispositivo: No application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sleep quality
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Daily functioning - Mood
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through study completion, approximately 2 months
Physical activity levels will be obtained using wearable monitors
Through study completion, approximately 2 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Device usability
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through study completion, approximately 2 months
Assessment of blood pressure
Through study completion, approximately 2 months
Weight
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Swiss Federal Institute of Technology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 maggio 2018

Completamento primario (Effettivo)

5 marzo 2019

Completamento dello studio (Effettivo)

30 ottobre 2020

Date di iscrizione allo studio

Primo inviato

4 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2018

Primo Inserito (Effettivo)

5 febbraio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • WESA_2017-01436

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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