NCT04225507

Technology-Supported Treatment of Sleep Apnea in Prediabetes

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea
• PreDiabetes
• Overweight or Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Diet and exercise coaching	All participants will receive diet and exercise goals and coaching.
OTHER	CPAP Treatment	CPAP treatment for sleep apnea and CPAP education and adherence coaching.

Timeline

• Start date: 2021-04-13
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2020-01-13
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States