Vital Sign EvaluationANNE One TMRCTNCT06995742
Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity
A study testing Device Array Use and Routine Vital Sign Measurement in people with Vital Sign Evaluation and Vital Sign Monitoring, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Sign Evaluation, Vital Sign Monitoring, Sleep Quality
- What is being tested?
- Device Array Use and Routine Vital Sign Measurement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.
Who cannot join
- Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Feinberg 16 West, Northwestern Memorial Hospital
Chicago, Illinois, 60611
Gregory R Smith Jr, MD MS, 312-926-5893, g.smith@nm.org
Gregory R Smith Jr, MD MS
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Gregory (Randy) R Smith Jr, MD MS, 312-926-5893, g.smith@nm.org
About this study
Official title: Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity: A Randomized Controlled Trial
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
- Being tested
- Device Array Use, Routine Vital Sign Measurement
- Keywords
- time motion study, vital signs, sleep quality, inpatient sleep, wireless device, patient satisfaction
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device Array UseDevice
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 MeasurementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention--Device Array Use | Experimental | Inpatients will wear the ANNE One device array for obtainment of vital sign assessments. Receives: Device: Device Array Use |
| Control--Routine Vital Sign Obtainment | Active comparator | Inpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device. Receives: Device: Routine Vital Sign Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Motion Assessment of Time Spent Obtaining and Recording Vital Signs
The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member.
Measured: 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.
Secondary outcomes (3)
Sleep Quality of Inpatient Study Participants
Sleep quality will be determined by use of the Potential Hospital Sleep Disruptions and Noises Questionnaire survey, administered to study participants after a night of study enrolment. The survey scores sleep quality from 1 to 5 with 1 signifying no disruption and 5 signifying extreme disruption.
Measured: Survey conducted 24-72 hours after enrolment.
Patient Satisfaction with Inpatient Sleep Quality
Question 8, "During this hospital stay, how often were you able to get the rest you needed?" of the Hospital Consumer Assessment of Healthcare Providers and Systems post-discharge questionnaire will be collected for study participants. Survey responses include: never, sometimes, usually, always.
Measured: Survey sent within a week of hospital discharge and collected within the subsequent thirty days.
Healthcare Provider Experience with the Vital Sign Device Array
Healthcare providers who use the device array will be surveyed with a Technology Acceptance Method survey to assess usability of the device array.
Measured: The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start2 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign EvaluationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Sibel Health Inc.
- Responsible party
- Principal investigator, Gregory Randall Smith Jr, Northwestern University
- Investigators
- Gregory (Randy) R Smith Jr, MD MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995742
- Sponsor's protocol ID
- STU00219340
- Other IDs
- 2023 Dixon Translational Grant
- Acronym
- ANNE One TMRCT
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ANNE One-Wellue Device Array Use on Staff Bedside Vital Sign Measurement Activity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06995742
- Acronym / sponsor ID
- ANNE One TMRCT / STU00219340
- Conditions
- Vital Sign Evaluation, Vital Sign Monitoring, Sleep Quality, Provider Behavior, Patient Satisfaction
- Keywords
- time motion study, vital signs, sleep quality, inpatient sleep, wireless device, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota, Sibel Health Inc.
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention--Device Array Use | Experimental | Device: Device Array UseInpatients will wear the ANNE One device array for obtainment of vital sign assessments. |
| Control--Routine Vital Sign Obtainment | Active comparator | Device: Routine Vital Sign MeasurementInpatients will have vital signs determined by routine practice, using any other standard of care-accepted method or device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients admitted to Northwestern Memorial Hospital, Feinberg Unit 16 West.
Key exclusion criteria (1 listed)
- Primary language other than English, under isolation status, pregnant patients, prisoners, employees or students of the hospital or Northwestern University.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device Array UseStudy 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. | Device | Intervention--Device Array Use |
| Routine Vital Sign MeasurementStudy participants randomized to the control arm will have their vital signs obtained by routine means, without use of the wireless vital sign device array. | Device | Control--Routine Vital Sign Obtainment |
Primary outcome
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.
The number of seconds spent by a healthcare provider obtaining and charting vital signs will be witnessed and recorded by a research staff member.
3 secondary outcomes
Sleep Quality of Inpatient Study Participants
Time frame: Survey conducted 24-72 hours after enrolment.
Patient Satisfaction with Inpatient Sleep Quality
Time frame: Survey sent within a week of hospital discharge and collected within the subsequent thirty days.
Healthcare Provider Experience with the Vital Sign Device Array
Time frame: The electronic survey will be administered twice during the study. Each survey will take approximately ten minutes to complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory (Randy) R Smith Jr, MD MS principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device Array Use and Routine Vital Sign Measurement in people with Vital Sign Evaluation and Vital Sign Monitoring, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory (Randy) R Smith Jr, MD MS (312-926-5893, g.smith@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.