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Healthy Adult ParticipantsRESTWELLNCT07589114

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

A study testing Mobile smartwatch application. in people with Healthy Adult Participants, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 2 sites in Romania.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult Participants
What is being tested?
Mobile smartwatch application.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesRomania
Study dates
19 Nov 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cosmin O. Popa, Assoc.Prof. contact

+40745092686

cosmin.popa@umfst.ro

Cristiana M. Cojocaru, Lecturer contact

+40757868711

cristiana-manuela.cojocaru@umfst.ro

Romania2 sites

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

    Târgu Mureş, Mureș County, 547565

    Cosmin O. Popa, Assoc.Prof., +40745092686, cosmin.popa@umfst.ro

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

    Târgu Mureş, Mureș County

Other trials in Romania

About this study

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.

Read the 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 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).

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.

Being tested
Mobile smartwatch application.
Keywords
digital intervention, sleep, emotion regulation, well-being, mental health, technology, REM sleep
Medical subject headings
Emotional Regulation, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07589114
Study groupRoleWhat they receive
TargetExperimentalThe haptic intervention delivered via Smartwatch will be applied in this group.
Receives: Device: Mobile smartwatch application.
ControlNo interventionThe haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Kessler Psychological Distress Scale (K10)

    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.

    Measured: Day 0 and 30.

  2. The PROMIS Scale

    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.

    Measured: Day 0 and 30.

Secondary outcomes (2)

  1. The Difficulties in Emotion Regulation Scale (DERS)

    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.

    Measured: Day 0 and 30.

  2. The PERMA Profiler

    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.

    Measured: Day 0 and 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start19 Nov 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589114
Sponsor's protocol ID
RESTWELL2026
Other IDs
PN-IV-P7-7.1-PTE-2024-0844
Acronym
RESTWELL
Status last verified
Nov 2026
First submitted
27 Apr 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38233280

  • 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.

    PubMed 37625326

  • 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.

    PubMed 35551058

  • 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.

    PubMed 36836540

  • 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.

    PubMed 30577441

Questions about this trial

What is this clinical trial studying?

A study testing Mobile smartwatch application. in people with Healthy Adult Participants, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 2 sites in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cosmin O. Popa, Assoc.Prof. (+40745092686, cosmin.popa@umfst.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Kessler Psychological Distress Scale (K10) (time frame: Day 0 and 30.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589114, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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