Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516614
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Sleep Coach for Adolescents With Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this work is to conduct a randomized trial evaluating the effects of a behavioral intervention to increase sleep duration and quality for adolescents with type 1 diabetes T1D The impact of the sleep-promoting intervention on executive function and glycemic outcomes will be assessed We will also explore multiple components of the recently identified central nervous system glymphatic system and evaluate how these components change and impact brain integrity and function with improved sleep
Detailed Description:
This randomized controlled trial will assess whether a behavioral coaching intervention to improve sleep duration and quality in adolescents with type 1 diabetes will improve glucose control and executive function We will recruit a sample of 150 adolescents with type 1 diabetes T1D and their caregivers at a single medical center We plan to recruit equal numbers of boys and girls and over-enroll youth from minoritized racial and ethnic groups After obtaining informed consentassent and baseline data we will randomize adolescents to the Sleep Coach condition n75 or the Enhanced Usual Care condition n75 Randomization will be computerized and adolescents will be stratified by diabetes device use insulin pumps continuous glucose monitors and age 11-14 years vs 15-17 years Adolescents and caregivers will complete survey measures again at 3 months 6 months and 12 months during regularly scheduled clinic visits Adolescents will complete the NIH Toolbox measures of executive function at each study visit Adolescents will be asked to wear a FitBit watch to assess sleep and complete sleep diaries at baseline and 3 months
Participants randomized to the Sleep Coach group will be sent a binder with intervention materials for the 4 sessions They will schedule individual phone calls with a trained member of the research team at a convenient time The first call is expected to last 20-30 minutes and the other calls are expected to last 10-15 minutes Caregivers will receive an overview of the sleep intervention content and they will be asked to support adolescents attempts to change sleep habits
Adolescents randomized to Enhanced Usual Care will receive diabetes education materials developed by our team for adolescents with T1D based on publicly available materials on diabetesorg Printed materials will be sent via mail and content will be shared via smart phone messages on the same schedule as participants randomized to the Sleep Coach intervention
A representative group of 50 of the 150 adolescents in the study will be invited to participate in an additional study visit prior to the intervention to obtain magnetic resonance imaging MRI of the brain Adolescents who agree to complete MRI of the brain will be asked to complete a follow-up visit approximately 6 months after the baseline visit following the same protocol and they will complete the daily sleep diary questions and share sleep data for another week
Participants randomized to the Sleep Coach group will be sent a binder with intervention materials for the 4 sessions They will schedule individual phone calls with a trained member of the research team at a convenient time The first call is expected to last 20-30 minutes and the other calls are expected to last 10-15 minutes Caregivers will receive an overview of the sleep intervention content and they will be asked to support adolescents attempts to change sleep habits
Adolescents randomized to Enhanced Usual Care will receive diabetes education materials developed by our team for adolescents with T1D based on publicly available materials on diabetesorg Printed materials will be sent via mail and content will be shared via smart phone messages on the same schedule as participants randomized to the Sleep Coach intervention
A representative group of 50 of the 150 adolescents in the study will be invited to participate in an additional study visit prior to the intervention to obtain magnetic resonance imaging MRI of the brain Adolescents who agree to complete MRI of the brain will be asked to complete a follow-up visit approximately 6 months after the baseline visit following the same protocol and they will complete the daily sleep diary questions and share sleep data for another week
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