Sleep Disorders Trial, Recruiting NCT06627504 Sponsor: University of Colorado, Denver Condition: Sleep Disorders
Back to Sleep Disorders

Sleep Disorders Trial, Recruiting

NCT06627504
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • High school students between the ages of 14 and 19 years old
  • People who have been diagnosed with Type 1 diabetes for at least one year
  • People who use an insulin pump or a similar automated device to manage their insulin
  • People who typically sleep 7 hours or less per night on school nights, as measured by a wrist-worn activity tracker
  • People who are above average weight (based on BMI measurements for their age) or who have a parent with obesity
  • People who are at a certain stage of physical development — stage 4 or 5 on a standard puberty scale, assessed based on breast development for girls and testicular size for boys (confirm with trial site)

Who may not be able to join:

  • People who have already been diagnosed with a sleep disorder, such as insomnia or sleep apnoea, or who score highly on a standard sleep disorder screening questionnaire
  • People who regularly take medications that affect sleep, such as stimulants, certain antipsychotic medications, melatonin, or other sleep aids
  • People who regularly take medications that affect insulin resistance, such as steroid medications or additional diabetes medications beyond their usual insulin
  • People whose HbA1c blood sugar level is 12% or higher (a measure of longer-term blood sugar control)
  • People who have had a severe illness or a serious diabetes-related complication called diabetic ketoacidosis within the past 60 days
  • People with an IQ below 70 or a serious mental health condition that affects sleep or the ability to take part in the study
  • People who work night shifts or have other regular commitments that would make it difficult to follow the trial's program

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Stacey L Simon, PhD, University of Colorado, Denver

Phone: 720-777-3491

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
12 August 2025
Est. completion
31 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Insulin Sensitivity; Cardiovascular Function; Glycemic Control

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov