NCT06516614 Sleep Coach for Adolescents With Type 1 Diabetes
| NCT ID | NCT06516614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-09-18 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) Inclusion criteria for caregivers: * Currently living with the child (at least 50% of the time) * Speak and read English
Contact & Investigator
Sarah Jaser, PhD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06516614 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 17 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06516614 currently recruiting?
Yes, NCT06516614 is actively recruiting participants. Contact the research team at lauren.l.milner@vumc.org for enrollment information.
Where is the NCT06516614 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT06516614 clinical trial?
NCT06516614 is sponsored by Vanderbilt University Medical Center. The principal investigator is Sarah Jaser, PhD at Vanderbilt University Medical Center. The trial plans to enroll 150 participants.
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