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临床试验/NCT07589114
NCT07589114招募中不适用

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

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2025年11月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
360
试验地点
2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究者

发起方
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
申办方类型
Other
责任方
Principal Investigator
主要研究者

Octavian Cosmin Popa

Associate Professor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

研究点 (2)

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