Clinical trial NCT06865781: Vital Signs Reduction Study
Official title: Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospitalization
Keywords: pediatric
hospitalization
vital signs
sleep
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Total sleep time
timeFrame: From enrollment to end of treatment at 24 hours
Secondary outcomes:
measure: Nocturnal wake frequency
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Nocturnal wake duration
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Total sleep time
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Overnight disruptions
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Restfulness upon waking
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Sleep disturbances
timeFrame: From enrollment to the end of treatment at 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Primary Children's Hospital
state: Utah
Study officials:
affiliation: Intermountain Primary Children's Hospital
name: Leandra Bitterfeld, MSN
role: PRINCIPAL_INVESTIGATOR
References: