Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04225507

Technology-Supported Treatment of Sleep Apnea in Prediabetes

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sleep Apnea Apnea Body Weight Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight or Obesity Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet and exercise coaching

Behavioral

All participants will receive diet and exercise goals and coaching.

CPAP Treatment

Other

CPAP treatment for sleep apnea and CPAP education and adherence coaching.

Primary outcomes

  1. Change from baseline 2-hour glucose levels at 6 months

    Time frame: Baseline and at 6 months

    Glucose levels will be measured at time=120min during oral glucose tolerance test

Secondary outcomes

  1. Change from baseline morning blood pressure at 6 months

    Time frame: Baseline and 6 months

    Morning blood pressure will be measured with a blood pressure cuff while sitting

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Northwestern University

Registry information

Acronym: TECH

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2020
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.