Validation of Fitbit Measurements in Hospitalized General Medicine Patients

Active, not recruiting

• Conditions: GIM Diagnosis; Medicine; Admission to GIM

• Registration Number: NCT07229833
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Patients admitted to the General Internal Medicine ward are sick and in need of monitoring that cannot be provided at home or treatments best administered in hospital. Standard care currently includes vital signs measurements and in some cases ECG. Wearable devices that continuous monitor patients could provided added information to improve the care of inpatients. This could include more monitoring and catching deterioration before it happens. Wearables have been shown to be largely accurate for monitoring heart rate, however it is still necessary to determine if they can reliably measure sleep, activity, and other health metrics. For this, study investigators are evaluating the validity of FitBit Sense 2 (or other FitBit devices) for measurement of sleep, activity, heart rate, respiratory rate, and oxygen saturation.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-06-01
• Study First Submitted: 2025-07-29
• Primary Completion: 2025-08-31
• Status Verified: 2025-10
• Study First Submitted QC: 2025-11-13
• Last Update Submitted: 2025-11-13
• Study First Posted: 2025-11-17
• Last Update Posted: 2025-11-17
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fitbit Sense 2 vs. StepWatch for activity (step count)	Collected over 24 hours in 1 min bins	Comparisons of step counts between Fitbit and Modus StepWatch
Fitbit Sense 2 vs. Nox T3 for heart rate (bpm)	Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins	Comparisons of HR between Fitbit and Nox pulse oximeter
Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute)	Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins.	Comparisons of RR between Fitbit and Nox RIP (respiratory inductive plethysmograph)
Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %)	Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins.	Comparisons of SpO2 between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for total sleep time (min)	Fitbit and Nox T3 collected during nighttime sleep (1 night)	Comparisons of sleep TST between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%)	Fitbit and Nox T3 collected during nighttime sleep (1 night)	Comparisons of SE between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min)	Fitbit and Nox T3 collected during nighttime sleep (1 night)	Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min)	Fitbit and Nox T3 collected during nighttime sleep (1 night)	Comparisons of WASO between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time	Fitbit and Nox T3 collected during nighttime sleep (1 night)	Comparisons of sleep onset time and wake time between Fitbit and Nox T3

Secondary Outcome Measures

Name	Time	Method
Fitbit Sense 2 vs. Sleep Diary for total sleep time (min)	Collected during nighttime sleep (1 night)	Comparisons of total sleep time between Fitbit and self-reported sleep diary.
Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%)	Collected during nighttime sleep (1 night)	Comparisons of sleep efficiency between Fitbit and self-reported sleep diary.
Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule	Collected during nighttime sleep (1 night)	Comparisons of time of sleep between Fitbit and self-reported sleep diary.
Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min)	Collected during nighttime sleep (1 night)	Comparisons of WASO between Fitbit and self-reported sleep diary.
Subgroup analysis based on gender	Collected at study baseline	Gender-based subgroup analysis of outcomes
Subgroup analysis based on comorbidities	Collected at study baseline	Descriptive data on participant comorbidities (e.g., presence of mobility limiting conditions, etc; yes/no) or subgroup analysis by comorbidities
Subgroup analysis based on use of walking aids	Collected at study baseline	Subgroup analysis by walking aid usage or descriptive data on walking aid use among participants (e.g., yes vs. no)

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada