NCT07589114

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Nov 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Nov 2025Feb 2027

Study Start

First participant enrolled

November 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

April 27, 2026

Last Update Submit

May 9, 2026

Conditions

Healthy Adult Participants

Keywords

digital interventionsleepemotion regulationwell-beingquality of lifemental healthtechnologyREM sleep

Outcome Measures

Primary Outcomes (3)

  • 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.

    Day 0 and 60.

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

    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

    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 Outcomes (2)

  • The Difficulties in Emotion Regulation Scale (DERS)

    Once in two weeks.

  • The PERMA Profiler

    Day 0, 30, and Day 60.

Study Arms (2)

Target

EXPERIMENTAL

The haptic intervention delivered via Smartwatch will be applied in this group.

Device: Mobile smartwatch application.

Control

NO INTERVENTION

The haptic intervention will not be delivered in this group, despite that participants will wear the Smartwatch during sleep.

Interventions

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.

Target

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age at least 18;
  • the ability to provide consent;
  • the absence of neurocognitive and severe psychiatric disorders.

You may not qualify if:

  • the presence of severe cognitive impairment;
  • the presence of psychosis;
  • inability to understand the informed consent and complete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Târgu Mureş, Mureș County, 547565, Romania

RECRUITING

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

Târgu Mureş, Mureș County, Romania

RECRUITING

Related Publications (5)

  • 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.

    PMID: 38233280BACKGROUND

  • 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.

    PMID: 37625326BACKGROUND

  • 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.

    PMID: 35551058BACKGROUND

  • 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.

    PMID: 36836540BACKGROUND

  • 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.

    PMID: 30577441BACKGROUND

MeSH Terms

Conditions

Emotional RegulationPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorPersonal Satisfaction

Central Study Contacts

Cosmin O. Popa, Assoc.Prof.

CONTACT

+40745092686cosmin.popa@umfst.ro

Cristiana M. Cojocaru, Lecturer

CONTACT

+40757868711cristiana-manuela.cojocaru@umfst.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 15, 2026

Study Start

November 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

RO(2)