RECRUITING

PICU-related Sleep and Circadian Dysregulation Pilot Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A single center pilot trial investigating the feasibility of using actigraphy and salivary melatonin levels to measure the sleep and circadian rhythm of critically ill children aged 3 to 6 years old. This study will also measure the feasibility of providing daytime light exposure as well as restricting all provided nutrition to during daytime hours.

Official Title

A Three-phase Pilot Study of the Feasibility of the Measurement and Promotion of Sleep and the Circadian Rhythm in a Pediatric Intensive Care Unit

Quick Facts

Study Start:2024-12-06
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06505447

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Child age 3 to 6 years old on the day of PICU admission
  2. 2. English-speaking parent at the bedside
  3. 3. Child expected to remain in the PICU over 24 to 48 hours
  1. 1. Child is in end-of-life care
  2. 2. The child is receiving neuromuscular blockade for any reason
  3. 3. Caregiver or parent not at the bedside

Contacts and Locations

Study Contact

Amanda B Hassinger, MD
CONTACT
716-323-0158
albrooks@buffalo.edu
Haiping Qiao, MS
CONTACT
716-323-0055
hqiao@upa.chob.edu

Study Locations (Sites)

John R. Oishei Children's Hospital
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • Sleep disruption
  • circadian rhythm
  • critical care
  • pediatrics

Additional Relevant MeSH Terms

  • Circadian Dysrhythmia
  • Sleep Disturbance
  • Critical Illness
  • Children, Only