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

NCT ID: NCT06363656

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2024-06-28

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

single-group

Participants who declare having problems with sleeping/insomnia

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

Intervention Type: DEVICE

• 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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Geraldo Lorenzi Filho

Director, Head of the Sleep Laboratory, Principal Investigator, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geraldo Lorenzi Filho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sleep Laboratory, Instituto do Coração, Hospital das Clínicas HCFMUSP

Locations

Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, , Brazil

Countries

Brazil

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Other Identifiers

76455623.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id