REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift (RESTWELL)
2026年5月9日 更新者：Octavian Cosmin Popa、George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
This study aims to explore the efficiency of a digital, Smartphone-delivered intervention for improving the quality of REM sleep on the mental health, emotion regulation and overall life quality of users.
調査の概要
詳細な説明
Building upon previous research regarding the use of digital solutions to enhance sleep quality, the primary objective of this study is to test the impact of using the REST-WELL application over a 60-day period within an adult sample.
The total sample will consist of 360 adult participants, students at the George Emil Palade University of Medicine, Pharmacy, Science and Technology, who will be randomly assigned to two groups: an experimental group of 180 participants, and a control group of 180 participants. Inclusion criteria involve a minimum age of 18 and the absence of diagnoses within the spectrum of neurocognitive, learning, or severe psychiatric disorders.
The present study will be conducted as part of the research project entitled "REM Sleep Augmentation Technology for Wellbeing, Affectivity, and Quality of Life Improvement" (unique registration code PN-IV-P7-7.1-PTE-2024-0844). Consequently, the group composition is based on the project proposal (300 participants, of whom 180 in the target group and 180 in the control group), based on the "matching groups" principle, requiring uniform distribution across groups in clinical trials. Participants in the experimental group will use the REST-WELL application via a smartwatch device for 60 nights. The data collection instruments will include:
- The Kessler Psychological Distress Scale (K10), administered on days 0 and 60, to measure adjustment difficulties;
- The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref), administered on days 0, 30, and 60, to assess general perceived wellbeing across various areas of functioning;
- The PROMIS Scale, administered bi-weekly, to measure sleep quality;
- The Difficulties in Emotion Regulation Scale (DERS), administered bi-weekly;
- The PERMA Profiler (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment), administered on days 0, 30, and 60.
Additionally, the analysis will include an evaluation of the students' academic performance in both groups, conducted on days 0 and 60, using the most recent exam session as a reference point.
研究の種類
介入
入学 (推定)
360
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。
研究連絡先
- 名前：Cosmin O. Popa, Assoc.Prof.
- 電話番号：+40745092686
- メール：cosmin.popa@umfst.ro
研究連絡先のバックアップ
- 名前：Cristiana M. Cojocaru, Lecturer
- 電話番号：+40757868711
- メール：cristiana-manuela.cojocaru@umfst.ro
研究場所
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Mureș County
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Târgu Mureş、Mureș County、ルーマニア、547565
- 募集
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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コンタクト：
- Cosmin O. Popa, Assoc.Prof.
- 電話番号：+40745092686
- メール：cosmin.popa@umfst.ro
-
Târgu Mureş、Mureș County、ルーマニア
- 募集
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- age at least 18;
- the ability to provide consent;
- the absence of neurocognitive and severe psychiatric disorders.
Exclusion Criteria:
- the presence of severe cognitive impairment;
- the presence of psychosis;
- inability to understand the informed consent and complete questionnaires.
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Target
The haptic intervention delivered via Smartwatch will be applied in this group.
|
An integrated system will be utilized, consisting of a mobile and Apple Watch application available in TestFlight (Apple's testing framework), comprising several components: the Sleep Data Collection Module, the Sleep Data Analysis Module, the Specific Sleep Cycle Detection Module, the Integration Module between sleep analysis and the haptic engine of the wearable device used, the Software Module for controlling the haptic engine and generating vibrations, and the Post-Haptic Intervention (vibration-based) Sleep Data Analysis Module.
|
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介入なし：Control
The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.
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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 |
|---|---|---|
|
The Kessler Psychological Distress Scale (K10)
時間枠：Day 0 and 60.
|
The Kessler Psychological Distress Scale (K10) measure adjustment difficulties, including 10 items.
In the present study, it will be used as a screening tool, higher levels indicating elevated distress, as follows: scores between 20-24 indicate the likelihood to present a mild disorder, scores between 25 and 29 indicate the likelihood to present a moderate disorder, while scores above 30 mean the possibility of a severe disorder.
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Day 0 and 60.
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The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref)
時間枠：Day 0, 30, and 60.
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The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref) is a measure of life quality, comprising multiple subscales like physical health, psychological health, social relationships and environment.
The raw scores ranges are the following: between 7 and 35 for Physical Health, between 6 and 30 for Psychological Health, between 3 and 15 for Social relationships, along with 8 and 40 for Environment.
Also, a transformed score involves a wide range between 0 and 100.
Higher scores represent a higher quality of life for the specific evaluated field.
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Day 0, 30, and 60.
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The PROMIS Scale
時間枠：Once in two weeks.
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The PROMIS Scale is a measure of the degree to which responders present sleeping difficultiesThe total scores ranges between 8 and 40, higher scores indicating the increased severity of sleep disturbances.
The raw scores are then converted to T scores, which can be interpreted as follows: final T score between 55 and 59 indicates mild intensity, between 60 and 69 moderate intensity, while T scores over 70 are equivalent to high severity.
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Once in two weeks.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Difficulties in Emotion Regulation Scale (DERS)
時間枠：Once in two weeks.
|
The Difficulties in Emotion Regulation Scale (DERS) constitutes a measure of various aspects of one's ability to modulate emotions, specifically emotional awareness and acceptance.
Raw scores range from 36 to 180, higher scores suggesting increased emotion regulation difficulties.
Severity categories are based on percentiles, responders presenting levels that correspond to the 96th percentile or above indicating very high emotion regulation difficulties.
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Once in two weeks.
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The PERMA Profiler
時間枠：Day 0, 30, and Day 60.
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The PERMA Profiler is a measure of well-being, involving six subscales, as follows: positive and negative emotions, engagement, relationships, meaning, accomplishment, as well as health.
Each item is rated using a scale from 0 to 10, the subscale scores being calculated as the mean of individual items.
A total score of minimum 9 is considered an indicator of very good functioning, while a score below 5 is thought to be a hallmark of malfunctioning.
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Day 0, 30, and Day 60.
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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。
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
- Chattu VK, Manzar MD, Kumary S, Burman D, Spence DW, Pandi-Perumal SR. The Global Problem of Insufficient Sleep and Its Serious Public Health Implications. Healthcare (Basel). 2018 Dec 20;7(1):1. doi: 10.3390/healthcare7010001.
- Philippe TJ, Sikder N, Jackson A, Koblanski ME, Liow E, Pilarinos A, Vasarhelyi K. Digital Health Interventions for Delivery of Mental Health Care: Systematic and Comprehensive Meta-Review. JMIR Ment Health. 2022 May 12;9(5):e35159. doi: 10.2196/35159.
- Zimmerman ME, Benasi G, Hale C, Yeung LK, Cochran J, Brickman AM, St-Onge MP. The effects of insufficient sleep and adequate sleep on cognitive function in healthy adults. Sleep Health. 2024 Apr;10(2):229-236. doi: 10.1016/j.sleh.2023.11.011. Epub 2024 Jan 16.
- Zhang H, Yang Y, Hao X, Qin Y, Li K. Effects of digital sleep interventions on sleep and psychological health during the COVID-19 pandemic: A systematic review and meta-analysis. Sleep Med. 2023 Oct;110:190-200. doi: 10.1016/j.sleep.2023.07.036. Epub 2023 Aug 17.
- Crisan CA, Milhem Z, Stretea R, Tata IM, Chereches RM, Miclutia IV. A Narrative Review on REM Sleep Deprivation: A Promising Non-Pharmaceutical Alternative for Treating Endogenous Depression. J Pers Med. 2023 Feb 10;13(2):306. doi: 10.3390/jpm13020306.
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)
2025年11月15日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年4月27日
QC基準を満たした最初の提出物
2026年5月9日
最初の投稿 (実際)
2026年5月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月15日
QC基準を満たした最後の更新が送信されました
2026年5月9日
最終確認日
2026年5月1日
詳しくは
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。