Sleep in Pediatric HSCT

Sleep Clinical Trial

Official title:

Sleep in Pediatric Hematopoietic Stem Cell Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106089
• Other study ID #: 18-015878
• Secondary ID: DCHS20PPR006
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep
• Stem Cell Transplant Complications

Intervention

Behavioral:
• Extended time between vitals check
Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	NJ Dept of Health Commission on Cancer Research, Rutgers University

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient acceptability questionnaire	Brief questionnaire evaluating the patient's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Parent acceptability questionnaire	Brief questionnaire evaluating the parent's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Nurse acceptability questionnaire	Brief questionnaire evaluating the nurse's acceptability of adjusting vitals checks.	15 days after transplant
Primary	Health-related quality of life (HRQL)	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	Actigraphy sleep efficiency	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
Secondary	Actigraphy total sleep time	This will measure the total amount of time the subject sleeps.	Day of the transplant through 15 days after the transplant
Secondary	Actigraphy number of awakenings	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