Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363656
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-08
Brief Title:
Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality an Observational Prospective Study - SleepEx2 Protocol
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality an Observational Prospective Study - SleepEx2 Protocol
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEP-EX2
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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None