Sleep Coach for Adolescents With Type 1 Diabetes
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT06516614
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sleep Coach — BEHAVIORALSleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
- Diabetes Education — BEHAVIORALParticipants will receive a a binder with educational information about diabetes and educational messages from the study team.
Study Details
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.
Key Dates
- Start date
- Sep 18, 2024
- Status verified
- Sep 2025
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Sleep-Promoting InterventionIndividualized sleep-promoting program for adolescents with type 1 diabetes
- Active Comparator: Enhanced Usual CareEducational Materials
Primary Outcome Measure
Sleep Duration [ Time Frame: 3 months ]
Central Contacts
- Lauren Milner, MPH615-875-7970
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | Lauren Milner, MPH |
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