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Completed

NCT Number: NCT04106089

Sleep in Pediatric HSCT

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.

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Key information

Conditions

Sleep Stem Cell Transplant Complications

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Extended time between vitals check

Behavioral

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

Primary outcomes

  1. Patient Acceptability Questionnaire

    Time frame: 15 days after transplant

    Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.

  2. Parent Acceptability Questionnaire

    Time frame: 15 days after transplant

    Brief questionnaire created for this study evaluating the patient's acceptability of adjusting vitals checks. Participants reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.

  3. Nurse Acceptability Questionnaire

    Time frame: 15 days after transplant

    Brief questionnaire created for this study evaluating the nurse's acceptability of adjusting vitals checks. Nurses reported agreement with each statement on a 5-point likert scale from not at all (1) to extremely (5). Higher values indicate greater agreement.

  4. Health-related Quality of Life (HRQL)

    Time frame: 15 days after transplant

    Using the Pediatric Quality of Life Inventory - Stem Cell Transplant (SCT) module. Scale values range from 0 to 100, with higher scores indicating better functioning.

Secondary outcomes

  1. 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.

  2. 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 each day in minutes.

  3. Actigraphy Awakenings-minutes Per Day

    Time frame: Day of the transplant through 15 days after the transplant

    This measure the number of minutes per day the subject awakens from rest during nighttime sleep per day.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • NJ Dept of Health Commission on Cancer Research
  • Rutgers University

Registry information

Official study title

Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2019
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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