N/A
N=50
Sleep in Pediatric HSCT
Sleep · Stem Cell Transplant Complications
Bottom Line
View on ClinicalTrials.gov: NCT04106089 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Patient Acceptability Questionnaire — 3.63; 3.55 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Extended time between vitals check (Behavioral)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Acceptability Questionnaire |
3.63; 3.55 | — |
| PRIMARY Parent Acceptability Questionnaire |
4.15; 3.88 | — |
| PRIMARY Nurse Acceptability Questionnaire |
3.89; 3.98 | — |
| PRIMARY Health-related Quality of Life (HRQL) |
76.22; 72.02 | — |
| SECONDARY Actigraphy Sleep Efficiency |
74.63; 80.56 | — |
| SECONDARY Actigraphy Total Sleep Time |
374.43; 474.19 | — |
| SECONDARY Actigraphy Awakenings-minutes Per Day |
122.44; 108.94 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04106089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.