Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol (SLEEP-EX2)

University of Sao Paulo General Hospital

Status

Completed

Conditions

Sleep Initiation and Maintenance Disorders

Health Status

Insomnia

Wearable Electronic Devices

Sleep

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT06363656

76455623.5.0000.0068

Details and patient eligibility

About

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?

Full 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.

Enrollment

158 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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.