Sleep Coach for Adolescents With Type 1 Diabetes
NCT Number: NCT06516614
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 1 Diabetes
Interventions: BEHAVIORAL: Sleep Coach|BEHAVIORAL: Diabetes Education
Sponsor: Vanderbilt University Medical Center
Sex: ALL
Age: CHILD
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2028-09

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.

Primary Outcome Measures: Sleep Duration, Total Sleep Time (average minutes per night) measured with Fitbit over 7 nights, 3 months|Sleep Variability, Individual difference in sleep duration (minutes) measured with Fitbit over 7 nights, 3 months
Secondary Outcome Measures: Executive Function BRIEF2, Behavior Rating Inventory of Executive Function 2nd Edition: 63-item measure, completed by parents to assess adolescent executive function in their daily life. Higher Global Executive Composite score indicates better executive function., 12 months|NIH Toolbox Dimensional Card Sort Test, Dimensional Change Card Sort Test takes 4 minutes for adolescents to complete on an iPad, assesses inhibition, a component of executive function, 12 months|NIH Toolbox List Sorting Working Memory Test, List Sorting Working Memory takes 8-10 minutes for adolescents to complete on an iPad, assesses working memory, a component of executive function, 12 months|Diabetes Management - Adolescent Report, Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care., 12 months|Diabetes Management - Parent Report, Self-Care Inventory-Short Form: 9-item measure, assesses key components of adolescent diabetes management. Higher mean scores indicate better diabetes self-care., 12 months|Sleep Quality, Pittsburgh Sleep Quality Index (PSQI): 21-item measure completed by adolescents, assesses sleep quality. Higher scores indicate poorer sleep quality., 12 months|Hemoglobin A1C, An indicator of average blood glucose levels. HbA1c is collected as part of usual care and will be extracted from adolescents' medical records, 12 months|Time in Range, Blood glucose levels, measured with continuous glucose monitors, that are within the target range (70-180 mg/dL) over 14 days. Time in Range is reported as a percentage and higher levels indicate better glycemic control., 12 months|Magnetic Resonance Imaging (MRI) of Brain: Glymphatic Flow, Fluid motion along perivascular spaces is assessed from MRI of the brian, 6 months|Fractional Anisotropy from MRI of the Brain, Fractional anisotropy is calculated from diffusion tensor imaging MRI. Higher FA is associated with better white matter integrity in the brain, 6 months