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RecruitingNCT07928141ClinicalTrials.gov record

Improving Sleep for Older Adults in the Emergency Department

Emergency Department Patient · Older Adults · Sleep Disturbance · FitBit

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Observational
Phase
Not applicable / not listed
Age range
70 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
78 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This quality improvement project aims to improve sleep for older adults during overnight stays in the Emergency Department. Older adults in the ED may experience prolonged stays while awaiting inpatient admission, and this period can involve sleep disruption, immobility, delirium risk, and physiologic stress. The first phase of the project will measure baseline sleep duration and related physiologic patterns among adults aged 70 years or older who are staying overnight in the ED and are admitted, or likely to be admitted, to Medicine.

Participants will be invited to wear a Fitbit Sense 2 device for approximately 24 hours. The device will collect sleep, heart rate, and activity data. Additional information will be collected through patient questionnaires and Epic chart review, including clinical and environmental factors that may affect sleep, such as ED location, overnight vital signs, bloodwork, imaging, medications, interventions, and delirium documentation. Fitbit data will be analyzed in aggregate and will not be used to guide real-time clinical care or flow into Epic.

After baseline sleep patterns and associated factors are better understood, the project will use quality improvement methods, including Plan-Do-Study-Act cycles, to introduce and evaluate practical sleep-improvement strategies through the Seniors Emergency Medicine Centre. Potential interventions may include reducing noise and lighting when clinically appropriate, providing sleep-support items such as earplugs and eye masks, using white noise, improving equipment and alarm management where safe, and considering sleep-promoting medications such as melatonin when appropriate. The primary outcome is total sleep time during the overnight ED stay, measured using Fitbit data. Secondary and balancing measures include patient satisfaction with wearing the Fitbit, delirium episodes, care delays related to sleep interventions, and staff feedback about workflow or device-related disruptions.

This project is intended to inform local improvements in care processes for older adults in the UHN Emergency Department and to support safer, more patient-centered overnight ED care. The QIRC submission identifies the project as a UHN quality improvement project focused on process change, information gathering, and evaluation, with an aim to improve overnight total sleep time for older adults by approximately one hour over six months after baseline measurement.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • Adults aged 70 years or older.
  • Patient is in the Emergency Department at Toronto General Hospital or Toronto Western Hospital.
  • Patient is admitted, or likely to be admitted, to the General Internal Medicine service.
  • Patient is expected to remain in the Emergency Department overnight.
  • Patient is able and willing to wear a wrist-worn wearable monitoring device for approximately 24 hours.
  • Patient provides consent to participate in the quality improvement project.

Exclusion Criteria:

  • Patient declines or is unable to provide consent.
  • Patient is unable to wear the wearable device safely or comfortably.
  • Patient has a clinical condition or care requirement that makes wearable monitoring inappropriate, as determined by the clinical or project team.
  • Patient is expected to leave the Emergency Department before overnight monitoring can occur.

Study population

Adults aged 70 years or older who are staying overnight in the Emergency Department at University Health Network and are admitted, or likely to be admitted, to the General Internal Medicine service. Participants will be invited to wear a wrist-worn wearable device to measure sleep, heart rate, and activity during the Emergency Department stay.

Understand screening

Treatment, groups and participation

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Assignment
Not reported
Masking
Not reported
Fitbit Sense 2 wearable monitoring DEVICE

Participants will wear a wrist-worn Fitbit Sense 2 during their ED/hospital stay for approximately 24 hours. The device will continuously collect physiological and activity data, including heart rate, step count, and sleep/wake patterns. The device will be applied by the study team with instructions for use and will be removed and collected at the end of the monitoring period. The wearable is used for passive data collection and does not provide treatment or alter routine clinical care.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Feasibility: device wear adherence (%)

Time frame: From enrollment to the end of observation at 24 hours

Percentage of enrolled participants who wear the Fitbit for at least 80% of the study period, based on clock time between device placement and removal, excluding periods when device removal is required for procedures or imaging.

Feasibility: heart rate data completeness (%)

Time frame: From enrollment to the end of observation at 24 hours

Percentage of participants with complete/usable heart rate (bpm) data collected during the study period.

Feasibility: activity (step count) data completeness (%)

Time frame: From enrollment to the end of observation at 24 hours

Percentage of participants with complete/usable activity (step count) data collected during the study period.

Feasibility: sleep data completeness (%)

Time frame: From enrollment to the end of observation at 24 hours

Percentage of participants with complete/usable sleep (total sleep time) data collected during the study period.

Acceptability: participation rate (%)

Time frame: At enrollment

Percentage of approached patients who agree to participate in the study and wear the device (Fitbit Sense 2) for 24 hours

Participant-reported acceptability (descriptive )

Time frame: At device removal (approximately 24 hours after device placement)

Acceptability of the Fitbit assessed using a brief post-monitoring open-ended question regarding overnight wear, comfort, and concerns about wearing the device. Responses are summarized descriptively.

Secondary measures

Heart Rate Metrics (bpm)

Time frame: From enrollment to the end of observation at 24 hours

Heart rate (beats per minute) measured using a wrist-worn wearable monitoring device (Fitbit Sense 2) during the study period

Activity (step count)

Time frame: From enrollment to the end of observation at 24 hours

Activity (step count) measured using a wrist-worn wearable monitoring device (Fitbit Sense 2) during the study period

Sleep: total sleep time (hours)

Time frame: From enrollment to the end of observation at 24 hours

Total sleep time (hours) collected using a wrist-worn wearable monitoring device (Fitbit Sense 2)

Sleep: number of awakenings (counts)

Time frame: From enrollment to the end of observation at 24 hours

Number of awakenings during the sleep period based on chart review data and Fitbit sleep data

Sleep: sleep stages (%, min)

Time frame: From enrollment to the end of observation at 24 hours

Sleep stages (REM, NREM: eg light/deep sleep) collected using a wrist-worn wearable monitoring device (Fitbit Sense 2)

Clinical outcomes: delirium (Y/N)

Time frame: From enrollment until hospital discharge (or ED disposition for patients who are not admitted), or up to 6 months, whichever occurs first

Development of delirium during the hospital stay, based on available chart review data, and its associations with wearable-derived data

Clinical Outcomes: length of stay

Time frame: From ED arrival to hospital discharge (or ED disposition for patients who are not admitted), or up to 6 months, whichever occurs first

Duration of hospital and ED stay (days and/or hours), and its associations with wearable-derived data

Clinical Outcomes: Disposition

Time frame: At hospital discharge (or ED disposition for non-admitted participants), or the participant's current care setting at 6 months after admission, whichever occurs first

Discharge disposition (eg home vs rehabilitation) based on chart review data, and its associations with wearable-derived data

Clinical comorbidities

Time frame: At enrollment

Type of clinical comorbidities based on chart review data

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Toronto General HospitalToronto, Ontario, CanadaRecruiting
Alice Tu (Clinical Research Coordinator)CONTACTAlice.Tu2@uhn.ca4372324852
Robert WuPRINCIPAL_INVESTIGATOR
View location on map ↗
Toronto Western HospitalToronto, CanadaRecruiting
Alice Tu (Clinical Research Coordinator)CONTACTAlice.Tu2@uhn.ca4372324852
Robert WuPRINCIPAL_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
University Health Network, Toronto
Study start
Apr 1, 2026 Actual
Primary completion
Dec 31, 2028 Estimated
Study completion
Dec 31, 2028 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Improving Sleep for Older Adults in the Emergency Department

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026