Actively Recruiting

Phase Not Applicable
Age: 11Years - 17Years
All Genders
NCT06516614

Sleep Coach for Adolescents With Type 1 Diabetes

Led by Vanderbilt University Medical Center · Updated on 2025-10-01

150

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sleep Coach for Adolescents With Type 1 Diabetes

Who Can Participate

Age: 11Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 11-17 years of age at enrollment
  • Diagnosed with type 1 diabetes for 12 months or more
  • Report insufficient sleep (<8 hours/night for 13-17 years, <9 hours/night for 11-12 years) without other sleep disorders or sleep apnea
  • HbA1c level above 7%
  • Able to read and speak English
  • Caregivers must live with the child at least 50% of the time and speak/read English
Not Eligible

You will not qualify if you...

  • Presence of other serious health conditions that interfere with diabetes management
  • For MRI subgroup: any condition preventing a quality brain MRI (e.g., metal implants or inability to remain still for up to 60 minutes)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Actively Recruiting

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Research Team

L

Lauren Milner, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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