An observational study in Emergency Department Patient, Older Adults and Sleep Disturbance, sponsored by University Health Network, Toronto. Recruiting at 2 sites in Canada. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University Health Network, Toronto · Observational
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.
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Feasibility: device wear adherence (%)
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.
Time frame: From enrollment to the end of observation at 24 hours
Feasibility: heart rate data completeness (%)
Percentage of participants with complete/usable heart rate (bpm) data collected during the study period.
Time frame: From enrollment to the end of observation at 24 hours
Feasibility: activity (step count) data completeness (%)
Percentage of participants with complete/usable activity (step count) data collected during the study period.
Time frame: From enrollment to the end of observation at 24 hours
Feasibility: sleep data completeness (%)
Percentage of participants with complete/usable sleep (total sleep time) data collected during the study period.
Time frame: From enrollment to the end of observation at 24 hours
Acceptability: participation rate (%)
Percentage of approached patients who agree to participate in the study and wear the device (Fitbit Sense 2) for 24 hours
Time frame: At enrollment
Participant-reported acceptability (descriptive )
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.
Time frame: At device removal (approximately 24 hours after device placement)
Heart Rate Metrics (bpm)
Heart rate (beats per minute) measured using a wrist-worn wearable monitoring device (Fitbit Sense 2) during the study period
Time frame: From enrollment to the end of observation at 24 hours
Activity (step count)
Activity (step count) measured using a wrist-worn wearable monitoring device (Fitbit Sense 2) during the study period
Time frame: From enrollment to the end of observation at 24 hours
Sleep: total sleep time (hours)
Total sleep time (hours) collected using a wrist-worn wearable monitoring device (Fitbit Sense 2)
Time frame: From enrollment to the end of observation at 24 hours
Sleep: number of awakenings (counts)
Number of awakenings during the sleep period based on chart review data and Fitbit sleep data
Time frame: From enrollment to the end of observation at 24 hours
Sleep: sleep stages (%, min)
Sleep stages (REM, NREM: eg light/deep sleep) collected using a wrist-worn wearable monitoring device (Fitbit Sense 2)
Time frame: From enrollment to the end of observation at 24 hours
Clinical outcomes: delirium (Y/N)
Development of delirium during the hospital stay, based on available chart review data, and its associations with wearable-derived data
Time frame: From enrollment until hospital discharge (or ED disposition for patients who are not admitted), or up to 6 months, whichever occurs first
Clinical Outcomes: length of stay
Duration of hospital and ED stay (days and/or hours), and its associations with wearable-derived data
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
Clinical Outcomes: Disposition
Discharge disposition (eg home vs rehabilitation) based on chart review data, and its associations with wearable-derived data
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
Clinical comorbidities
Type of clinical comorbidities based on chart review data
Time frame: At enrollment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Parasomnias
University Health Network, Toronto →