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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

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).

The total sample will consist of about 150 adult participants from the general population, who will be assigned to the target (experimental) group or the control group, through simple randomization.

The inclusion criteria involve: age between 18 and 65 years, use of a compatible iPhone, wearing either a personal Apple Watch or one provided by the project, and provision of written informed consent. The exclusion criteria include diagnosed 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; and pregnancy.

Informed consent will be obtained both in person and online, using a Google Forms questionnaire.

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.

The data collection instruments will include:

  • The Kessler Psychological Distress Scale (K10) to measure adjustment difficulties;
  • The PROMIS Scale to measure sleep quality;
  • The Difficulties in Emotion Regulation Scale (DERS);
  • The PERMA Profiler (Positive Emotions, Engagement, Relationships, Meaning, and Accomplishment).

All instruments will be administered on day 0 and 30.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Target

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

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.

Ingen inngripen: Control

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Kessler Psychological Distress Scale (K10)
Tidsramme: Day 0 and 30.

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 30.
The PROMIS Scale
Tidsramme: Day 0 and 30.

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.

Day 0 and 30.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Difficulties in Emotion Regulation Scale (DERS)
Tidsramme: Day 0 and 30.

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.

Day 0 and 30.
The PERMA Profiler
Tidsramme: Day 0 and 30.

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 and 30.

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

19. november 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

27. april 2026

Først innsendt som oppfylte QC-kriteriene

9. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • RESTWELL2026
  • PN-IV-P7-7.1-PTE-2024-0844 (Annet stipend/finansieringsnummer: Romanian Ministry of Education through CNFIS)

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