Technology-Supported Treatment of Sleep Apnea in Prediabetes

Not Applicable

Recruiting

• Conditions: PreDiabetes; Overweight or Obesity; Sleep Apnea
• Interventions: Behavioral: Diet and exercise coaching; Other: CPAP Treatment

• Registration Number: NCT04225507
• Lead Sponsor: University of Chicago

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2021-04-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Diet and exercise coaching	Diet and exercise.
Lifestyle Plus CPAP Intervention	CPAP Treatment	CPAP treatment, diet and exercise.
Lifestyle Plus CPAP Intervention	Diet and exercise coaching	CPAP treatment, diet and exercise.

Primary Outcome Measures

Name	Time	Method
Change from baseline 2-hour glucose levels at 6 months	Baseline and at 6 months	Glucose levels will be measured at time=120min during oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Change from baseline morning blood pressure at 6 months	Baseline and 6 months	Morning blood pressure will be measured with a blood pressure cuff while sitting

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States