Intermountain Primary Children's Hospital
Salt Lake City, Utah, 84112, United States
NCT Number: NCT06865781
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.
This study is active but is not currently recruiting participants.
1 year–18 year
All sexes
Interventional
Not applicable
Salt Lake City, Utah, 84112, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400
Time frame: From enrollment to end of treatment at 24 hours
Measured by actigraphy
Time frame: From enrollment to the end of treatment at 24 hours
By actigraphy
Time frame: From enrollment to the end of treatment at 24 hours
By actigraphy
Time frame: From enrollment to the end of treatment at 24 hours
By self report via sleep diary
Time frame: From enrollment to the end of treatment at 24 hours
By self report via sleep diary
Time frame: From enrollment to the end of treatment at 24 hours
By self report via sleep diary
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
Intermountain Health Care, Inc.
Other
Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
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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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