Examination of Sleep and Family Functioning in Pediatric Craniopharyngioma Patients

Craniopharyngioma Clinical Trial

Official title:

Examining Sleep and Family Functioning in Pediatric Craniopharyngioma Using Ecological Momentary Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330080
• Other study ID #: SAFF
• Status: Completed
• Start date: February 12, 2018
• Est. completion date: January 29, 2019

Study information

• Verified date: March 2019
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 29, 2019
• Est. primary completion date: January 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Craniopharyngioma diagnosis

• Access to smartphone or a tablet

• Agreement to download Ilumivu application

• The ability for the participant to answer questionnaires (i.e., no cognitive or developmental diagnoses that would preclude understanding and completing child self-report questionnaires)

• Age between 8 and 18 years old at the time of enrollment onto St. Jude protocol RT2CR.

• Participated in sleep study component of RT2CR

Exclusion Criteria:

• Limited English proficiency as evidenced by an inability to read and respond to EMA survey questions

• Visual or sensorimotor impairment (e.g., loss of sight)

Related Conditions & MeSH terms

• Craniopharyngioma

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participation	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.	Once at enrollment

External Links

•   clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital