Recruiting

Sleep Coach

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06516614

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

Interventions

Sleep Coach

Diabetes Education

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06516614

Start date

Sep 18, 2024

Status verified date

Sep, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sleep-Promoting Intervention

Individualized sleep-promoting program for adolescents with type 1 diabetes

active comparator: Enhanced Usual Care

Educational Materials

Interventions

Sleep Coach

Sleep-promoting intervention consisting of 4 phone sessions to improve sleep duration and consistency.

Diabetes Education

Participants will receive a a binder with educational information about diabetes and educational messages from the study team.

Primary outcome measure

  • Sleep Duration [ Time Frame: 3 months ]
  • Sleep Variability [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Lauren Milner, MPH

615-875-7970lauren.l.milner@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Lauren Milner, MPH

lauren.l.milner@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-10-01.