NCT06363656

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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?

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-02-15
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2024-04-12
• Last updated: 2024-08-07

Locations

1 site across 1 country: Brazil