What this study is
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.
What's being tested
- Sleep Coach
Intervention · BEHAVIORAL
Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.
- Diabetes Education
Intervention · BEHAVIORAL
Participants will receive a a binder with educational information about diabetes and educational messages from the study team.
Study details
- Official title
- Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Type 1 Diabetes
- Enrolling
- 150 people
- Starts
- 2024-09-18
- Est. completion
- 2028-09
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 11 Years – 17 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 11-17 years of age at the time of enrollment
- Diagnosed with type 1 diabetes for ≥ 12 months
- Report insufficient sleep (< 8 hrs./night for 13-17 year-olds, <9 hrs./night for 11-12 year-olds) but have no other sleep disorders or sleep apnea
- Are not meeting the target for HbA1c (<7%)
- Able to read /speak English
You can't join if
- Participant has other serious health conditions that interfere with diabetes management
- Optional MRI portion of the study - anything that would prevent an adolescent from receiving a high-quality MRI of the brain (metal implants or inability to hold still for an MRI which may take up to 60 minutes)
caregivers
You may qualify if
- Currently living with the child (at least 50% of the time)
- Speak and read English
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashville, Tennessee, United States
- Lauren Milner, MPH · Contactlauren.l.milner@vumc.org
Recruiting
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 230074
Principal investigator
Sarah Jaser, PhD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.