RECRUITING

Sleep Coach for Adolescents With Type 1 Diabetes

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sleep Promoting Intervention to Improve Diabetes Outcomes and Executive Function in Adolescents With T1D

Quick Facts

Study Start:2024-09-18
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06516614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 11-17 years of age at the time of enrollment
  2. * Diagnosed with type 1 diabetes for ≥ 12 months
  3. * Report insufficient sleep (\< 8 hrs./night on an average of 3 out of 5 school nights) but have no other sleep disorders or sleep apnea
  4. * Are not meeting the target for HbA1c (\<7%)
  5. * Able to read /speak English
  1. * Participant has other serious health conditions that interfere with diabetes management
  2. * 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)
  3. * Currently living with the child (at least 50% of the time)
  4. * Speak and read English

Contacts and Locations

Study Contact

Lauren Milner, MPH
CONTACT
615-875-7970
lauren.l.milner@vumc.org

Principal Investigator

Sarah Jaser, PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Sarah Jaser, PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2028-09

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes