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OpenTrials
Completed

NCT Number: NCT06363656

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

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?

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Key information

Conditions

Insomnia Dyssomnias Health Status Mental Disorders Nervous System Diseases Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Wearable Electronic Devices

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

About this study

Participants will answer questionnaires about overall health status, sleep quality and insomnia at the beginning, at 16 days follow-up, and at the end of the study. Participants must use the smartwatch for at least a 12-hour period that includes night time, during a minimum of 30 consecutive days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (30 years old or more);
  • Minimum score of 7 on Pittsburgh Sleep Quality Index;
  • Capable of giving consent.

Exclusion criteria

  • Night shift workers;
  • Skin condition that may interfere with optic sensor readings - such as Lupus, Atopic Dermatitis, Vitiligo;
  • Tattoo on the wrist area that may interfere with optic sensor readings;
  • Allergies or sensitivities to the components/materials of the smartwatch;
  • Health condition that may be considered risky/unsafe by the medical team;
  • Pregnant women.

Treatment and study plan

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

Device
  • 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)

Primary outcomes

  1. Concordance between the smartwatch application and clinical assessment

    Time frame: 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).

    Intraclass correlation coefficient calculated between sleep characteristics captured by the smartwatch and scores of all questionnaires

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: SLEEP-EX2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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