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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PreDiabetes; Sleep Apnea; Overweight or Obesity
• Intervention / Treatment: Behavioral: Diet and exercise coaching; Other: CPAP Treatment

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 Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle Intervention; Diet and exercise.	Behavioral: Diet and exercise coaching; All participants will receive diet and exercise goals and coaching.
Experimental: Lifestyle Plus CPAP Intervention; CPAP treatment, diet and exercise.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University
• Investigators: Principal Investigator: Esra Tasali, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Sleep Apnea Syndromes; Prediabetic State; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Diet; Continuous Positive Airway Pressure
• Other Study ID Numbers: IRB19-1445; R01DK120312 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No