REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift (RESTWELL)
2026년 5월 9일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
360
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Cosmin O. Popa, Assoc.Prof.
- 전화번호: +40745092686
- 이메일: cosmin.popa@umfst.ro
연구 연락처 백업
- 이름: Cristiana M. Cojocaru, Lecturer
- 전화번호: +40757868711
- 이메일: cristiana-manuela.cojocaru@umfst.ro
연구 장소
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Mureș County
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Târgu Mureş, Mureș County, 루마니아, 547565
- 모병
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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연락하다:
- Cosmin O. Popa, Assoc.Prof.
- 전화번호: +40745092686
- 이메일: cosmin.popa@umfst.ro
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Târgu Mureş, Mureș County, 루마니아
- 모병
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Target
The haptic intervention delivered via Smartwatch will be applied in this group.
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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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간섭 없음: Control
The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Kessler Psychological Distress Scale (K10)
기간: Day 0 and 60.
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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)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Difficulties in Emotion Regulation Scale (DERS)
기간: Once in two weeks.
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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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 11월 15일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 2월 1일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 9일
처음 게시됨 (실제)
2026년 5월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 9일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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