Recruiting

Bluetooth Vital Signs

Sponsor:

Northwestern University

Code:

NCT06995742

Conditions

Vital Sign Evaluation

Vital Sign Monitoring

Sleep Quality

Provider Behavior

Patient Satisfaction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Device Array Use

Routine Vital Sign Measurement

Study Details

Brief summary:

Randomized controlled trial of a time motion study of time spent obtaining and charting vital signs for inpatients, comparing use of a wireless Bluetooth vital sign array as intervention versus routine vital sign obtainment activity on a general medical floor.

Conditions

Vital Sign Evaluation

Vital Sign Monitoring

Sleep Quality

Provider Behavior

Patient Satisfaction

Study ID

NCT06995742

Start date

Jun 2, 2025

Status verified date

Jun, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.

Exclusion Criteria:

  • Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention--Device Array Use

Inpatients will wear the ANNE One device array for obtainment of vital sign assessments.

active comparator: Control--Routine Vital Sign Obtainment

Inpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device.

Interventions

Device Array Use

Study participants assigned to the intervention study arm will wear a wireless Bluetooth capable vital sign detection array, with one device externally worn on each of their chest, one finger, and one arm, with healthcare providers using an additional oral temperature probe.

Routine Vital Sign Measurement

Study participants randomized to the control arm will have their vital signs obtained by routine means, without use of the wireless vital sign device array.

Primary outcome measure

  • Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs [ Time Frame: Number of seconds spent obtaining and charting vital signs is obtained at 8a daily, for maximum of three days for each study participant, and are added together to equal the total time spent on vital sign assessment. ]

Central Contacts and Locations

Central contacts

Gregory (Randy) R Smith Jr, MD MS

312-926-5893g.smith@nm.org

Jane S Kim, MS MEd

312-926-7272jane.kim@northwestern.edu

Locations

Feinberg 16 West, Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Gregory R Smith Jr, MD MS

312-926-5893g.smith@nm.org

Principal Investigator:

Gregory R Smith Jr, MD MS

More Information

Sponsor

Northwestern University

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Keywords

  • time motion study
  • vital signs
  • sleep quality
  • inpatient sleep
  • wireless device
  • patient satisfaction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2025-06-05.