Technology-Supported Treatment of Sleep Apnea in Prediabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Technology-Supported Treatment of Sleep Apnea in Prediabetes

Conditions
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Sleep Apnea, PreDiabetes, Overweight or Obesity

Intervention / Treatment
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* Behavioral: Diet and exercise coaching
* Other: CPAP Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lifestyle Intervention<br>Diet and exercise. | Behavioral: Diet and exercise coaching<br>* All participants will receive diet and exercise goals and coaching.<br>|
| Experimental: Lifestyle Plus CPAP Intervention<br>CPAP treatment, diet and exercise. | Behavioral: Diet and exercise coaching<br>* All participants will receive diet and exercise goals and coaching.<br>Other: CPAP Treatment<br>* CPAP treatment for sleep apnea and CPAP education and adherence coaching.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 2-hour glucose levels at 6 months | Glucose levels will be measured at time=120min during oral glucose tolerance test | Baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline morning blood pressure at 6 months | Morning blood pressure will be measured with a blood pressure cuff while sitting | Baseline and 6 months |