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NCT Number: NCT07589114

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

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.

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Key information

Conditions

Healthy Adult Participants Behavior Emotional Regulation Personal Satisfaction Psychological Well-Being Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures, Târgu Mureş, Mureș County, Romania

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile smartwatch application.

Device

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.

Primary outcomes

  1. The Kessler Psychological Distress Scale (K10)

    Time frame: Day 0 and 60.

    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.

  2. The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref)

    Time frame: Day 0, 30, and 60.

    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.

  3. The PROMIS Scale

    Time frame: Once in two weeks.

    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.

Secondary outcomes

  1. The Difficulties in Emotion Regulation Scale (DERS)

    Time frame: Once in two weeks.

    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.

  2. The PERMA Profiler

    Time frame: Day 0, 30, and Day 60.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cosmin O. Popa, Assoc.Prof.

CONTACT

[email protected]

+40745092686

Cristiana M. Cojocaru, Lecturer

CONTACT

[email protected]

+40757868711

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: RESTWELL

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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