Validation of Fitbit Measurements in Hospitalized General Medicine Patients

November 13, 2025 updated by: Robert Wu, University Health Network, Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population will be General Internal Medicine inpatients on the GIM wards. Patients who can provide informed consent will be approached for enrollment. Exclusion criteria are patients who are purely palliative and therefore in which vital sign measurement would be inappropriate.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
General internal medicine patients admitted to General Medicine Wards

Intervention: Fitbit Sense 2 (Fitbit, San Francisco, CA, USA)

Gold standard devices: To compare measures, patients will be asked to wear the following for 24 hours:

  • Sleep study device - Nox T3 chest band with oximeter. Participants will be asked to wear this for 24 hours. The Nox T3 monitors chest movement and determines sleep stages. It is paired with a Nonin oximeter. This provides continuous oxygen saturation monitoring as well as heart rate and respiratory rate.
  • Step counter - An ankle-worn Stepwatch Activity Monitor which has been validated in hospital patients who move slowly.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Collected over 24 hours in 1 min bins
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
Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins
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)
Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins.
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
Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins.
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
Fitbit and Nox T3 collected during nighttime sleep (1 night)
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
Fitbit and Nox T3 collected during nighttime sleep (1 night)
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
Fitbit and Nox T3 collected during nighttime sleep (1 night)
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
Fitbit and Nox T3 collected during nighttime sleep (1 night)
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
Fitbit and Nox T3 collected during nighttime sleep (1 night)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Collected during nighttime sleep (1 night)
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.
Collected during nighttime sleep (1 night)
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.
Collected during nighttime sleep (1 night)
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.
Collected during nighttime sleep (1 night)
Subgroup analysis based on gender
Time Frame: Collected at study baseline
Gender-based subgroup analysis of outcomes
Collected at study baseline
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
Collected at study baseline
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)
Collected at study baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-5399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study requested sharing of IPD in the ethics application.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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