- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07589114
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift (RESTWELL)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cosmin O. Popa, Assoc.Prof.
- Número de teléfono: +40745092686
- Correo electrónico: cosmin.popa@umfst.ro
Copia de seguridad de contactos de estudio
- Nombre: Cristiana M. Cojocaru, Lecturer
- Número de teléfono: +40757868711
- Correo electrónico: cristiana-manuela.cojocaru@umfst.ro
Ubicaciones de estudio
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Mureș County
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Târgu Mureş, Mureș County, Rumania, 547565
- Reclutamiento
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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Contacto:
- Cosmin O. Popa, Assoc.Prof.
- Número de teléfono: +40745092686
- Correo electrónico: cosmin.popa@umfst.ro
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Târgu Mureş, Mureș County, Rumania
- Reclutamiento
- George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: Control
The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Kessler Psychological Distress Scale (K10)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Difficulties in Emotion Regulation Scale (DERS)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RESTWELL2026
- PN-IV-P7-7.1-PTE-2024-0844 (Otro número de subvención/financiamiento: Romanian Ministry of Education through CNFIS)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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