Clinical trial NCT06363656: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
Official title: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Sleep Initiation and Maintenance Disorders
Health Status
Wearable Electronic Devices
Sleep
Keywords: Wearable Electronic Devices
Insomnia
Sleep Quality
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 158
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Primary outcomes:
measure: Concordance between the smartwatch application and clinical assessment
timeFrame: 1) at the beginning (start); 2) at the 16-days follow-up (middle); 3) at the 30-days follow-up (end).
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: Sleep Laboratory, Instituto do Coração, Hospital das Clínicas HCFMUSP
name: Geraldo Lorenzi Filho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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