Trial Outcomes & Findings for Sleep in Pediatric HSCT (NCT NCT04106089)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

15 days after transplant

Results posted on

2024-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Observation-Intervention-Observation 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Overall Study STARTED	29	21
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep in Pediatric HSCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observation-Intervention-Observation n=29 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=21 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Total n=50 Participants Total of all reporting groups
Age, Continuous	14.38 years STANDARD_DEVIATION 3.50 • n=5 Participants	13.62 years STANDARD_DEVIATION 3.69 • n=7 Participants	14.06 years STANDARD_DEVIATION 3.58 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	21 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days after transplant

Population: 40 patients completed the full study and reported on acceptability at day 15

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.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=22 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=18 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Patient Acceptability Questionnaire	3.63 units on a scale Standard Deviation 1.61	3.55 units on a scale Standard Deviation 1.46

PRIMARY outcome

Timeframe: 15 days after transplant

Population: 40 patients completed the study, but not all patients had a parent participate, thus the total number of parents reporting data is 37

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.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=19 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=18 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Parent Acceptability Questionnaire	4.15 units on a scale Standard Deviation 0.89	3.88 units on a scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: 15 days after transplant

Population: 40 patients completed the full study, this is data reported by nurses about those 40 patients

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.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=22 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=18 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Nurse Acceptability Questionnaire	3.89 units on a scale Standard Deviation 0.96	3.98 units on a scale Standard Deviation 0.90

PRIMARY outcome

Timeframe: 15 days after transplant

Population: 40 participants who completed the study completed this measure

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.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=22 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=18 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Health-related Quality of Life (HRQL)	76.22 units on a scale Standard Deviation 17.13	72.02 units on a scale Standard Deviation 13.48

SECONDARY outcome

Timeframe: Day of the transplant through 15 days after the transplant

Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here

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.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=10 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=17 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Actigraphy Sleep Efficiency	74.63 percentage of time in bed spent asleep Standard Deviation 19.02	80.56 percentage of time in bed spent asleep Standard Deviation 16.64

SECONDARY outcome

Timeframe: Day of the transplant through 15 days after the transplant

Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here

This will measure the total amount of time the subject sleeps each day in minutes.

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=10 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=17 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Actigraphy Total Sleep Time	374.43 minutes slept per day Standard Deviation 150.31	474.19 minutes slept per day Standard Deviation 141.11

SECONDARY outcome

Timeframe: Day of the transplant through 15 days after the transplant

Population: 27 of 40 patients who completed the study had evaluable actigraphy data, presented here

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

Outcome measures

Outcome measures
Measure	Observation-Intervention-Observation n=10 Participants 5 days of observation, 5 days of extended vitals check, 5 days returning to regular vitals checks Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)	Observation-Observation-Intervention n=17 Participants 5 days of observation, 5 more days of observation, 5 days of extended vitals check Extended time between vitals check: Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Actigraphy Awakenings-minutes Per Day	122.44 minutes per day Standard Deviation 100.21	108.94 minutes per day Standard Deviation 96.66

Adverse Events

Observation-Intervention-Observation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation-Observation-Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lauren Daniel

Rutgers University Camden

Phone: 856-225-6535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place