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

August 5, 2024 updated by: Geraldo Lorenzi Filho, University of Sao Paulo General Hospital

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Any participant that reports sleep problems or insomnia screened by the open survey sent to different groups in the city of Sao Paulo (Brazil).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single-group
Participants who declare having problems with sleeping/insomnia
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between the smartwatch application and clinical assessment
Time Frame: 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
1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Samsung Eletrônica da Amazônia Ltda
Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

Investigators

  • Principal Investigator: Geraldo Lorenzi Filho, MD, PhD, Sleep Laboratory, Instituto do Coração, Hospital das Clínicas HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Actual)

June 28, 2024

Study Completion (Actual)

June 28, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 76455623.5.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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