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

Recruiting
30 years of age
Both
Phase N/A

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Overview

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?

Description

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.

Eligibility

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.

Study details

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

NCT06363656

University of Sao Paulo General Hospital

29 April 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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