Technology-Supported Treatment of Sleep Apnea in Prediabetes (TECH)

The University of Chicago

Status: Enrolling

Conditions: Overweight or Obesity; Sleep Apnea; PreDiabetes

Treatments: Behavioral: Diet and exercise coaching; Other: CPAP Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04225507

IRB19-1445

R01DK120312 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Lifestyle Intervention

Other group

Description:

Diet and exercise.

Treatment:

Behavioral: Diet and exercise coaching

Lifestyle Plus CPAP Intervention

Experimental group

Description:

CPAP treatment, diet and exercise.

Treatment:

Other: CPAP Treatment

Behavioral: Diet and exercise coaching