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

May 9, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Romania
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 547565
        • Recruiting
        • George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures
        • Contact:
      • Târgu Mureş, Mureș County, Romania
        • Recruiting
        • George Emil Palade University of Medicine, Pharmacy, Science and Technology of Targu Mures

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Target
The haptic intervention delivered via Smartwatch will be applied in this group.
Device: Mobile smartwatch application.
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.
No Intervention: Control
The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 and 60.
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.
Day 0, 30, and 60.
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.
Once in two weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once in two weeks.
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.
Day 0, 30, and Day 60.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 9, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESTWELL2026
  • PN-IV-P7-7.1-PTE-2024-0844 (Other Grant/Funding Number: Romanian Ministry of Education through CNFIS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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