Ignite Creation Date:
2024-10-25 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642246
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Sleep Promotion and Pediatric Hypertension
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sleep Promotion Among Children Newly Diagnosed With Essential Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting to increase sleep duration and reduce systolic and diastolic blood pressure
Detailed Description:
Insufficient sleep is associated with hypertension in children Despite this knowledge sleep promotion is not considered as a behavioral target during the initial treatment of pediatric essential hypertension Investigators are developing a mobile platform to promote sleep in children that may have utility for treating pediatric essential hypertension
The overall objective of this study is to determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting to increase sleep duration and reduce systolic and diastolic blood pressure
This is a home-based single-site study of 13-to-18-year-olds N10 5 parent-child dyads Participants will have a recent diagnosis of essential hypertension based on clinical ambulatory blood pressure monitoring with initial treatment targeting lifestyle modification without pharmacological therapy Participants must have cellular or internet access and spend less than or equal to 75 hours in bed per night Children will be excluded if they have a known clinical sleep disorder
The sleep promotion intervention will be delivered using REDCap All participants will be provided with a sleep tracker to monitor their sleep patterns throughout the study A two-week run-in phase will be used to capture baseline sleep patterns and a home sleep polysomnography test will be completed to provide clinical sleep data During a 7-week intervention phase all participants will receive the same intervention condition Participants will be provided a sleep duration goal paired with a loss-framed financial incentive virtual account starting with deductions each time the sleep goal is not met will be sent sleep guidance text messages and will receive weekly performance feedback text messages Further at the end of the intervention phase participants will undergo a second Ambulatory Blood Pressure Monitoring ABPM The primary outcome is acceptance and feasibility of completing this study captured via self-reported feedback and documenting compliance with the study protocol The secondary outcomes are changes in sleep duration from baseline and changes in daytime and nocturnal systolic and diastolic blood pressure from baseline
The overall objective of this study is to determine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting to increase sleep duration and reduce systolic and diastolic blood pressure
This is a home-based single-site study of 13-to-18-year-olds N10 5 parent-child dyads Participants will have a recent diagnosis of essential hypertension based on clinical ambulatory blood pressure monitoring with initial treatment targeting lifestyle modification without pharmacological therapy Participants must have cellular or internet access and spend less than or equal to 75 hours in bed per night Children will be excluded if they have a known clinical sleep disorder
The sleep promotion intervention will be delivered using REDCap All participants will be provided with a sleep tracker to monitor their sleep patterns throughout the study A two-week run-in phase will be used to capture baseline sleep patterns and a home sleep polysomnography test will be completed to provide clinical sleep data During a 7-week intervention phase all participants will receive the same intervention condition Participants will be provided a sleep duration goal paired with a loss-framed financial incentive virtual account starting with deductions each time the sleep goal is not met will be sent sleep guidance text messages and will receive weekly performance feedback text messages Further at the end of the intervention phase participants will undergo a second Ambulatory Blood Pressure Monitoring ABPM The primary outcome is acceptance and feasibility of completing this study captured via self-reported feedback and documenting compliance with the study protocol The secondary outcomes are changes in sleep duration from baseline and changes in daytime and nocturnal systolic and diastolic blood pressure from baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None