Technology-Supported Treatment of Sleep Apnea in Prediabetes

  • Interventional
  • Recruiting
  • NCT04225507
Eligibility Details Visit

Technology-Supported Treatment of Sleep Apnea in Prediabetes

Despite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.

This is a 6-month randomized controlled, parallel group trial with two arms. After baseline, the subjects will be randomized to lifestyle intervention alone (lifestyle group) or lifestyle plus CPAP intervention (lifestyle plus CPAP group). The same metabolic and cardiovascular assessments will be performed at baseline and after 6-months of intervention.

     The lifestyle group will aim to achieve a weight loss through diet and exercise. The lifestyle plus CPAP group will additionally receive CPAP treatment. All subjects will use a custom smartphone app to track weight loss and/or CPAP goals and will receive weekly coaching phone calls to maximize treatment adherence.


Age Group
20 Years to 65 Years

Accepting Healthy Volunteers?

Inclusion Criteria:

         - Overweight or obese

         - Prediabetes

         - Sleep apnea

        Exclusion Criteria:

         - Diabetic

         - enrolled in a formal weight loss program

         - Any underlying disease likely to limit life span and/or increase risk of interventions

At a Glance

National Government IDNCT04225507


Lead SponsorUniversity of Chicago

Lead PhysicianEsra Tasali


20 Years to 65 Years