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Sleep in Pediatric HSCT

NCT04106089 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-18

Study results available
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Summary

Through an aggregated N=1 randomized controlled design (each patient will serve as their own control, with the 5-day intervention period determined by randomization), the current study will test the acceptability, feasibility, and impact on sleep and supportive care engagement of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.

Conditions

  • Sleep
  • Stem Cell Transplant Complications

Interventions

BEHAVIORAL

Extended time between vitals check

Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Sponsors & Collaborators

Principal Investigators

  • Lamia Barakat, PhD · CHOP

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106089 on ClinicalTrials.gov