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

Completed

• Conditions: Sleep; Sleep Initiation and Maintenance Disorders; Health Status; Wearable Electronic Devices; Insomnia
• Interventions: Device: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires

• Registration Number: NCT06363656
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single-group	Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires	Participants who declare having problems with sleeping/insomnia

Primary Outcome Measures

Name	Time	Method
Concordance between the smartwatch application and clinical assessment	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

Trial Locations

Locations (1)

Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 São Paulo, Brazil