Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients
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|ClinicalTrials.gov Identifier: NCT03330080|
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 8, 2019
Pediatric craniopharyngioma patients experience significant endocrine and sleep dysregulation difficulties. Sleep is a crucial part of children's healthy development, and sleep difficulties are associated with severe functional morbidity. Insufficient sleep, excessive daytime sleepiness, and poor sleep quality have all been significantly related to academic, behavioral, and emotional functioning in children and adolescents. Ecological momentary assessments (EMA) will be used to collect observational data.
EMA data will be collected twice daily for one week. For the morning EMA administration, participants will be asked about their sleep. During the evening administration, participants will be asked about their daytime sleepiness, overall well-being, and family functioning. Covariates also administered during the evening administration include medication administration (Y/N) and total screen time. At the end of the EMA data collection period (on day 7 OR 8), participants will be sent a survey asking them to report - anonymously - their overall experience and satisfaction with the EMA data collection method.
|Condition or disease|
After recruitment and informed consent/assent is obtained for the current study, participants will be asked to complete a questionnaire battery online (via REDCap) assessing sleep habits, daytime sleepiness, family routines, family functioning, and overall quality of life in the past six months. The relationship between subjective sleep ratings obtained from the parent craniopharyngioma study at St. Jude (RT2CR) at diagnosis and 3 months later (T1 and T2) and family functioning/routines at the follow-up study (T3) will be assessed. The researchers have permission to use data for all participants who consent to participate in this follow-up EMA study.
Children will be sent electronic surveys two times per day (i.e., morning and evening) for seven days using Ilumivu software (https://ilumivu.com/mema-demo). Ilumivu is an established EMA tool that offers an in-mobile app for participants to respond to questionnaires in real time with limited burden. This application will send notifications to participants to remind them to complete surveys and record response times for each survey.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment|
|Actual Study Start Date :||February 12, 2018|
|Actual Primary Completion Date :||January 29, 2019|
|Actual Study Completion Date :||January 29, 2019|
Ecological momentary assessment (EMA)
The ecological momentary assessment (EMA) will be used for participants to complete surveys from home on two occasions each day over seven days.
- Rate of participation [ Time Frame: Once at enrollment ]Study feasibility will be assessed by calculating the participation rate as follows: the number of participants who agree to participants divided by the number who are approached to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330080
|United States, Tennessee|
|St . Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Valerie Crabtree, PhD||St. Jude Children's Research Hospital|