- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07589114
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift (RESTWELL)
This study aims to explore the efficiency of a digital, Smartphone-delivered intervention for improving the quality of sleep on the mental health and emotion regulation of users.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 30-day period within an adult sample.
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).
The total sample will consist of about 150 adult participants from the general population, who will be assigned to the target (experimental) group or the control group, through simple randomization.
The inclusion criteria involve: age between 18 and 65 years, use of a compatible iPhone, wearing either a personal Apple Watch or one provided by the project, and provision of written informed consent. The exclusion criteria include diagnosed neurocognitive disorders, learning disorders, and severe psychiatric disorders; use of medications that affect REM sleep; diagnosed sleep disorders, specifically sleep apnea, narcolepsy, or treated insomnia; night-shift work; and pregnancy.
Informed consent will be obtained both in person and online, using a Google Forms questionnaire.
Participants in the experimental group will use the application for 30 nights. The application detects REM sleep episodes and delivers brief haptic vibrations during a maximum of five REM episodes per night. The smart alarm provides gentle vibrations within the 30-minute period preceding the scheduled wake-up time, followed by a full vibration at the set time.
Participants in the control group will wear the Apple Watch for sleep monitoring over 30 nights, without receiving nocturnal vibrations or using the smart alarm feature.
The data collection instruments will include:
- The Kessler Psychological Distress Scale (K10) to measure adjustment difficulties;
- The PROMIS Scale to measure sleep quality;
- The Difficulties in Emotion Regulation Scale (DERS);
- The PERMA Profiler (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment).
All instruments will be administered on day 0 and 30.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Cosmin O. Popa, Assoc.Prof.
- Telefonní číslo: +40745092686
- E-mail: cosmin.popa@umfst.ro
Studijní záloha kontaktů
- Jméno: Cristiana M. Cojocaru, Lecturer
- Telefonní číslo: +40757868711
- E-mail: cristiana-manuela.cojocaru@umfst.ro
Studijní místa
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Mureș County
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Târgu Mureş, Mureș County, Rumunsko, 547565
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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Kontakt:
- Cosmin O. Popa, Assoc.Prof.
- Telefonní číslo: +40745092686
- E-mail: cosmin.popa@umfst.ro
-
Târgu Mureş, Mureș County, Rumunsko
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- age between 18 and 65 years;
- use of a compatible iPhone;
- wearing either a personal Apple Watch or one provided by the project
- ability to provide the informed consent.
Exclusion Criteria:
- the presence of neurocognitive disorders, learning disorders, and severe psychiatric disorders;
- use of medications that affect REM sleep;
- diagnosed sleep disorders, specifically sleep apnea, narcolepsy, or treated insomnia;
- night-shift work;
- pregnancy;
- inability to understand the informed consent and complete questionnaires.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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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Žádný zásah: Control
The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Kessler Psychological Distress Scale (K10)
Časové okno: Day 0 and 30.
|
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. |
Day 0 and 30.
|
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The PROMIS Scale
Časové okno: Day 0 and 30.
|
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. |
Day 0 and 30.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Difficulties in Emotion Regulation Scale (DERS)
Časové okno: Day 0 and 30.
|
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. |
Day 0 and 30.
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The PERMA Profiler
Časové okno: Day 0 and 30.
|
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. |
Day 0 and 30.
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- RESTWELL2026
- PN-IV-P7-7.1-PTE-2024-0844 (Jiné číslo grantu/financování: Romanian Ministry of Education through CNFIS)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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