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Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol

NCT06363656 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2024-08-07

No results posted yet for this study

Summary

The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.

The main question it aims to answer is:

\- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?

Conditions

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
  • Health Status
  • Wearable Electronic Devices
  • Sleep

Interventions

DEVICE

Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires

* Synchronization of smartwatch with smartphone (internet connection) to send sleep characteristics captured by the application * Weight * Height * Body measurements (circumferences) * Questionnaires about overall health status * Pittsburgh Sleep Quality Index questionnaire * Insomnia Severity Index * Sleep Hygiene Index * Epworth Sleepiness Scale * NoSAS score (Neck, Obesity, Snoring, Age, Sex)

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Geraldo Lorenzi Filho, MD, PhD · Sleep Laboratory, Instituto do Coração, Hospital das Clínicas HCFMUSP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2024-06-28
Completion
2024-06-28

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06363656 on ClinicalTrials.gov