Sleep in Pediatric HSCT

February 6, 2023 updated by: Children's Hospital of Philadelphia

Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Context: Patients undergoing treatment for cancer face disease, treatment, and environmental obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and quantity due to overnight vitals checks, medication administration, blood draws, and environmental noise and light. For patients undergoing hematopoietic stem cell transplant (HSCT), the risk for poor sleep is especially high due to protracted hospitalization, frequent vitals checks resulting in multiple night awakenings, and high symptom burden peaking approximately 10 days post-transplant.

Objectives:

Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT recovery.

Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and engagement in supportive care on the oncology unit.

Study Design:

Aggregated N=1 randomized controlled design. All participants will undergo a 5 day observation and then be randomized to receive the 5 day intervention (extended vitals checks) during either nights of days +5-+9 or days +10-+14.

Setting/Participants:

Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP)

Study Interventions and Measures:

Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at night.

Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary, and complete self- and parent-proxy psychosocial measures (symptom burden, health related quality of life, sleep) and acceptability. Medical record review will also be conducted to assess vitals check frequency.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

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.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females age 8 to 21 years.
  2. Undergoing HSCT at The Children's Hospital of Philadelphia
  3. Parent/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  1. History of developmental delays given the relationship to sleep/wake patterns
  2. Sleep disorder diagnosis as documented in the medical record
  3. Cognitive delays that impact the ability to complete study measures
  4. Not proficient in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Observation-Intervention-Observation
5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks
Behavioral: Extended time between vitals check
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
EXPERIMENTAL: Observation-Observation-Intervention
5 days of observation, 5 more days of observation, 5 days of extended vitals check
Behavioral: Extended time between vitals check
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptability questionnaire
Time Frame: 15 days after transplant
Brief questionnaire evaluating the patient's acceptability of adjusting vitals checks.
15 days after transplant
Parent acceptability questionnaire
Time Frame: 15 days after transplant
Brief questionnaire evaluating the parent's acceptability of adjusting vitals checks.
15 days after transplant
Nurse acceptability questionnaire
Time Frame: 15 days after transplant
Brief questionnaire evaluating the nurse's acceptability of adjusting vitals checks.
15 days after transplant
Health-related quality of life (HRQL)
Time Frame: Baseline visit (1-2 days before transplant), 5 days after transplant, 10 days after transplant, and 15 days after transplant
Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module
Baseline visit (1-2 days before transplant), 5 days after transplant, 10 days after transplant, and 15 days after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actigraphy sleep efficiency
Time Frame: Day of the transplant through 15 days after the transplant
Sleep efficiency is the percentage of time spent asleep, while in bed. It is calculated by dividing the time spent asleep, by the total amount of time in bed.
Day of the transplant through 15 days after the transplant
Actigraphy total sleep time
Time Frame: Day of the transplant through 15 days after the transplant
This will measure the total amount of time the subject sleeps.
Day of the transplant through 15 days after the transplant
Actigraphy number of awakenings
Time Frame: Day of the transplant through 15 days after the transplant
This measure the number of times the subject awakens from rest, whether sleep or a nap.
Day of the transplant through 15 days after the transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Rutgers University
NJ Dept of Health Commission on Cancer Research

Investigators

  • Principal Investigator: Lamia Barakat, PhD, CHOP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (ACTUAL)

November 18, 2019

Primary Completion (ACTUAL)

December 1, 2022

Study Completion (ACTUAL)

December 1, 2022

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (ACTUAL)

September 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 18-015878
  • DCHS20PPR006 (OTHER_GRANT: NJ Dept of Health Commission on Cancer Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on Extended time between vitals check

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe