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ReclutandoNCT07928141Registro de ClinicalTrials.gov

Improving Sleep for Older Adults in the Emergency Department

Emergency Department Patient · Older Adults · Sleep Disturbance · FitBit

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
70 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
78 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Población del estudio

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Feasibility: device wear adherence (%)

Plazo: 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 (%)

Plazo: 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 (%)

Plazo: 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 (%)

Plazo: 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 (%)

Plazo: 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 )

Plazo: 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.

Medidas secundarias

Heart Rate Metrics (bpm)

Plazo: 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)

Plazo: 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)

Plazo: 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)

Plazo: 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)

Plazo: 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)

Plazo: 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

Plazo: 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

Plazo: 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

Plazo: At enrollment

Type of clinical comorbidities based on chart review data

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

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Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Toronto General HospitalToronto, Ontario, CanadaReclutando
Alice Tu (Clinical Research Coordinator)CONTACTAlice.Tu2@uhn.ca4372324852
Robert WuPRINCIPAL_INVESTIGATOR
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Toronto Western HospitalToronto, CanadaReclutando
Alice Tu (Clinical Research Coordinator)CONTACTAlice.Tu2@uhn.ca4372324852
Robert WuPRINCIPAL_INVESTIGATOR
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Equipo y fechas

Patrocinador principal
University Health Network, Toronto
Inicio del estudio
1 abr 2026 Real
Finalización primaria
31 dic 2028 Estimado
Finalización del estudio
31 dic 2028 Estimado
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Improving Sleep for Older Adults in the Emergency Department

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026