REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Mobile smartwatch application.
  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 (vibra

Первичные конечные точки

• The Kessler Psychological Distress Scale (K10) [Срок оценки: Day 0 and 60.]
• The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref) [Срок оценки: Day 0, 30, and 60.]
• The PROMIS Scale [Срок оценки: Once in two weeks.]

Вторичные конечные точки (2)

• The Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Once in two weeks.]
• The PERMA Profiler [Срок оценки: Day 0, 30, and Day 60.]

Критерии участия

Критерии включения

• age at least 18;
• the ability to provide consent;
• the absence of neurocognitive and severe psychiatric disorders.

Критерии исключения

• the presence of severe cognitive impairment;
• the presence of psychosis;
• inability to understand the informed consent and complete questionnaires.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Румыния · 2 центра

• George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures — Târgu Mureş
• George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures — Târgu Mureş

Публикации

• 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. PMID 38233280
• 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. PMID 37625326
• 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. PMID 35551058
• 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. PMID 36836540
• 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. PMID 30577441

Идентификаторы

NCT: NCT07589114 · RESTWELL2026 · PN-IV-P7-7.1-PTE-2024-0844

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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