NCT06516614Recruiting
Sleep Coach for Adolescents With Type 1 Diabetes
Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 17 Jul 2024
- Start date
- 18 Sept 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT06516614
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 18 Sept 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Participant has other serious health conditions that interfere with diabetes management
Who the study is looking for
- 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
- Currently living with the child (at least 50% of the time)
- Speak and read English
Age in the registry: 11 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.