CompletedNo phase
Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol
Key facts
- Who runs it
- University of Sao Paulo General Hospital
- Where
- Brazil1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 158 people enrolled
- Started
- 15 Feb 2024
- Ended
- 28 Jun 2024
- Type of study
- Observational
- Treatments tested
- Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires
- Record updated
- 7 August 2024
Who can take part
- Age
- 30 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Adults (30 years old or more)
- Minimum score of 7 on Pittsburgh Sleep Quality Index
- Capable of giving consent
Who cannot take part
- Skin condition that may interfere with optic sensor readings - such as Lupus, Atopic Dermatitis, Vitiligo
- Allergies or sensitivities to the components/materials of the smartwatch
- Health condition that may be considered risky/unsafe by the medical team
- Night shift workers
- Tattoo on the wrist area that may interfere with optic sensor readings
- Pregnant women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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?
The group in the trial
- single-group
Participants who declare having problems with sleeping/insomnia
Treatment: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 7 August 2024