Improving Sleep for Older Adults in the Emergency Department
NCT07928141, Recruiting, University Health Network, Toronto
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Improving Sleep for Older Adults in the Emergency Department | ClinicalTrials.gov |
| NCT number | NCT07928141 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 78 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Health Network, Toronto | ClinicalTrials.gov |
| Conditions | Emergency Department Patient, Older Adults, Sleep Disturbance, FitBit | ClinicalTrials.gov |
| Interventions | Fitbit Sense 2 wearable monitoring | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Feasibility: device wear adherence (%) | 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. | ClinicalTrials.gov |
| Primary | Feasibility: heart rate data completeness (%) | 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. | ClinicalTrials.gov |
| Primary | Feasibility: activity (step count) data completeness (%) | 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. | ClinicalTrials.gov |
| Primary | Feasibility: sleep data completeness (%) | 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. | ClinicalTrials.gov |
| Primary | Acceptability: participation rate (%) | At enrollment | Percentage of approached patients who agree to participate in the study and wear the device (Fitbit Sense 2) for 24 hours | ClinicalTrials.gov |
| Primary | Participant-reported acceptability (descriptive ) | 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. | ClinicalTrials.gov |
| Secondary | Heart Rate Metrics (bpm) | 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 | ClinicalTrials.gov |
| Secondary | Activity (step count) | 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 | ClinicalTrials.gov |
| Secondary | Sleep: total sleep time (hours) | 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) | ClinicalTrials.gov |
| Secondary | Sleep: number of awakenings (counts) | 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 | ClinicalTrials.gov |
| Secondary | Sleep: sleep stages (%, min) | 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) | ClinicalTrials.gov |
| Secondary | Clinical outcomes: delirium (Y/N) | 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 | ClinicalTrials.gov |
| Secondary | Clinical Outcomes: length of stay | 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 | ClinicalTrials.gov |
| Secondary | Clinical Outcomes: Disposition | 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 | ClinicalTrials.gov |
| Secondary | Clinical comorbidities | At enrollment | Type of clinical comorbidities based on chart review data | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)