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Active, Not Recruiting

NCT Number: NCT06865781

Vital Signs Reduction Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Primary Children's Hospital

Salt Lake City, Utah, 84112, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Forgone overnight vital signs

Other

No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400

Primary outcomes

  1. Total sleep time

    Time frame: From enrollment to end of treatment at 24 hours

    Measured by actigraphy

Secondary outcomes

  1. Nocturnal wake frequency

    Time frame: From enrollment to the end of treatment at 24 hours

    By actigraphy

  2. Nocturnal wake duration

    Time frame: From enrollment to the end of treatment at 24 hours

    By actigraphy

  3. Total sleep time

    Time frame: From enrollment to the end of treatment at 24 hours

    By self report via sleep diary

  4. Overnight disruptions

    Time frame: From enrollment to the end of treatment at 24 hours

    By self report via sleep diary

  5. Restfulness upon waking

    Time frame: From enrollment to the end of treatment at 24 hours

    By self report via sleep diary

  6. Sleep disturbances

    Time frame: From enrollment to the end of treatment at 24 hours

    By self report via Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Official study title

Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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