Vital Signs Reduction Study

Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children

Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.

Study Overview

• Status: Active, not recruiting
• Conditions: Hospitalization
• Intervention / Treatment: Other: Forgone overnight vital signs

Detailed Description

Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Intermountain Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
• Age 1-18 years
• Pediatric Early Warning Score ≤ 1 at 2000
• A parent/home caregiver present to consent to study
• Patient and home caregiver speak English or Spanish.
• Deemed appropriate for forgone overnight vital signs by care team (attending MD/Advanced Practice Provider and bedside RN).

Exclusion Criteria:

• Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
• Patients requiring O2 monitoring at home.
• The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
• Anaphylaxis within 24 hours
• Within the first 24 hours post-operative period
• Requiring oxygen above baseline
• Fever in the last 24 hours.
• Sepsis alert in the last 72 hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Receive standard of care vital signs
Experimental: Intervention group; Will not receive vital signs at 0000 or 0400 of study night.	Other: Forgone overnight vital signs; No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	Measured by actigraphy	From enrollment to end of treatment at 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal wake frequency	By actigraphy	From enrollment to the end of treatment at 24 hours
Nocturnal wake duration	By actigraphy	From enrollment to the end of treatment at 24 hours
Total sleep time	By self report via sleep diary	From enrollment to the end of treatment at 24 hours
Overnight disruptions	By self report via sleep diary	From enrollment to the end of treatment at 24 hours
Restfulness upon waking	By self report via sleep diary	From enrollment to the end of treatment at 24 hours
Sleep disturbances	By self report via Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey	From enrollment to the end of treatment at 24 hours

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Leandra Bitterfeld, MSN, Intermountain Primary Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: sleep; pediatric; hospitalization; vital signs
• Other Study ID Numbers: 1052853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will not be shared because participant consent does not include data sharing outside of the study team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No