Recruiting

Sleep Improvement

Sponsor:

University Health Network, Toronto

Code:

NCT07928141

Conditions

Emergency Department Patient

Older Adults

Sleep Disturbance

FitBit

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Fitbit Sense 2 wearable monitoring

Study Details

Brief summary:

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.

Conditions

Emergency Department Patient

Older Adults

Sleep Disturbance

FitBit

Study ID

NCT07928141

Start date

Apr 1, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

78 participants

Anticipated

Interventions and Outcome Measures

Interventions

Fitbit Sense 2 wearable monitoring

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.

Primary outcome measure

  • Feasibility: device wear adherence (%) [ Time Frame: From enrollment to the end of observation at 24 hours ]
  • Feasibility: heart rate data completeness (%) [ Time Frame: From enrollment to the end of observation at 24 hours ]
  • Feasibility: activity (step count) data completeness (%) [ Time Frame: From enrollment to the end of observation at 24 hours ]
  • Feasibility: sleep data completeness (%) [ Time Frame: From enrollment to the end of observation at 24 hours ]
  • Acceptability: participation rate (%) [ Time Frame: At enrollment ]
  • Participant-reported acceptability (descriptive ) [ Time Frame: At device removal (approximately 24 hours after device placement) ]

Central Contacts and Locations

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Alice Tu (Clinical Research Coordinator)

4372324852Alice.Tu2@uhn.ca

Principal Investigator:

Robert Wu

Toronto Western Hospital

Recruiting

Toronto, Canada, M5T 2S8

Contacts

Alice Tu (Clinical Research Coordinator)

4372324852Alice.Tu2@uhn.ca

Principal Investigator:

Robert Wu

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 10, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.