Reducing overnight vital signs to improve sleep in hospitalized children
Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children
This study is testing if skipping overnight vital sign checks can help hospitalized children sleep better and longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06865781 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of forgoing overnight vital signs on the sleep quality and duration of children hospitalized in medical-surgical units. Eligible participants will be randomly assigned to either receive standard vital signs monitoring or to forgo these checks during the night. The study will last approximately 24 hours, during which participants will wear an actigraphy watch to measure sleep patterns and complete surveys regarding their sleep experience. The primary focus is to assess total sleep time, while secondary outcomes will evaluate sleep disruptions and overall restfulness.
Who should consider this trial
Good fit: Ideal candidates are hospitalized children aged 1-18 years at Primary Children's Hospital who are stable and do not require intensive monitoring.
Not a fit: Patients with pre-existing conditions that affect sleep or require continuous monitoring will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved sleep quality for hospitalized children, enhancing their recovery experience.
How similar studies have performed: While the approach of reducing vital sign checks is novel, similar studies have suggested that minimizing disruptions during sleep can improve patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Salt Lake City, Utah
- Intermountain Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Leandra Bitterfeld, MSN — Intermountain Primary Children's Hospital
- Study coordinator: Leandra Bitterfeld, MSN
- Email: Leandra.Bitterfeld@imail.org
- Phone: 8016621000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.