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Enhancement of Sleep With Wearables (WESA)

2021年3月2日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

33

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • スイス
    • Zurich
      • Zürich、Zurich、スイス、8092
        • Swiss Federal Institute of Technology

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～84年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Application of tones
During non-rapid eye movement (NREM) sleep short tones will be played
デバイス：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
偽コンパレータ：No application of tones
During NREM sleep no short tones will be played
デバイス：No application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Sleep quality
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Daily functioning - Mood
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Through study completion, approximately 2 months
Physical activity levels will be obtained using wearable monitors
Through study completion, approximately 2 months

その他の成果指標

結果測定
メジャーの説明
時間枠
Device usability
時間枠：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
時間枠：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]
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Through study completion, approximately 2 months
Assessment of blood pressure
Through study completion, approximately 2 months
Weight
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Swiss Federal Institute of Technology

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年5月7日

一次修了 (実際)

2019年3月5日

研究の完了 (実際)

2020年10月30日

試験登録日

最初に提出

2017年12月4日

QC基準を満たした最初の提出物

2018年1月26日

最初の投稿 (実際)

2018年2月5日

学習記録の更新

投稿された最後の更新 (実際)

2021年3月3日

QC基準を満たした最後の更新が送信されました

2021年3月2日

最終確認日

2021年3月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • WESA_2017-01436

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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Application of tonesの臨床試験

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