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OpenTrials
Completed

NCT Number: NCT07229833

Validation of Fitbit Measurements in Hospitalized General Medicine Patients

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.

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Key information

Conditions

GIM Diagnosis Admission to GIM Medicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, M5G2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Subject inclusion criteria.

  • General internal medicine patients admitted to General Medicine Wards.
  • Able to consent.
  • 18 years of age or older

Subject exclusion criteria.

  • Patients who are purely palliative "comfort measures only" where measuring vital signs would not be appropriate and will be excluded.
  • To reduce the potential risk of transmitting nosocomial infections, patients under contact precautions for methicillin resistant Staphylococcus aureus (MRSA) and Clostridium difficile infections will also be excluded.
  • This study will also exclude patients at risk of vascular compromise of the arm or leg on which the wearable device was to be placed, such as patients with deep venous thrombosis, dialysis fistulas, and severe upper extremity trauma.
  • Expected discharge less than 24 hours

Treatment and study plan

Primary outcomes

  1. Fitbit Sense 2 vs. StepWatch for activity (step count)

    Time frame: Collected over 24 hours in 1 min bins

    Comparisons of step counts between Fitbit and Modus StepWatch

  2. Fitbit Sense 2 vs. Nox T3 for heart rate (bpm)

    Time frame: 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

  3. Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute)

    Time frame: 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)

  4. Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %)

    Time frame: 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

  5. Fitbit Sense 2 vs. Nox T3 for total sleep time (min)

    Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)

    Comparisons of sleep TST between Fitbit and Nox T3

  6. Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%)

    Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)

    Comparisons of SE between Fitbit and Nox T3

  7. Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min)

    Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)

    Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3

  8. Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min)

    Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)

    Comparisons of WASO between Fitbit and Nox T3

  9. Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time

    Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)

    Comparisons of sleep onset time and wake time between Fitbit and Nox T3

Secondary outcomes

  1. Fitbit Sense 2 vs. Sleep Diary for total sleep time (min)

    Time frame: Collected during nighttime sleep (1 night)

    Comparisons of total sleep time between Fitbit and self-reported sleep diary.

  2. Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%)

    Time frame: Collected during nighttime sleep (1 night)

    Comparisons of sleep efficiency between Fitbit and self-reported sleep diary.

  3. Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule

    Time frame: Collected during nighttime sleep (1 night)

    Comparisons of time of sleep between Fitbit and self-reported sleep diary.

  4. Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min)

    Time frame: Collected during nighttime sleep (1 night)

    Comparisons of WASO between Fitbit and self-reported sleep diary.

  5. Subgroup analysis based on gender

    Time frame: Collected at study baseline

    Gender-based subgroup analysis of outcomes

  6. Subgroup analysis based on comorbidities

    Time frame: Collected at study baseline

    Descriptive data on participant comorbidities (e.g., presence of mobility limiting conditions, etc; yes/no) or subgroup analysis by comorbidities

  7. Subgroup analysis based on use of walking aids

    Time frame: Collected at study baseline

    Subgroup analysis by walking aid usage or descriptive data on walking aid use among participants (e.g., yes vs. no)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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