Health Status, Insomnia, Sleep, Sleep Initiation and Maintenance Disorders, Wearable Electronic Devices
Conditions
Keywords
Wearable Electronic Devices, Insomnia, Sleep Quality
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.
Interventions
DEVICEWears 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)
Sponsors
University of Sao Paulo General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed