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 — BEHAVIORAL
    Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
  • Diabetes Education — BEHAVIORAL
    Participants 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 Intervention
    Individualized sleep-promoting program for adolescents with type 1 diabetes
  • Active Comparator: Enhanced Usual Care
    Educational Materials

Primary Outcome Measure

Sleep Duration [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212
Lauren Milner, MPH

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