Technology-Supported Treatment of Sleep Apnea in Prediabetes

NCT ID: NCT04225507

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2026-07-31

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.

Conditions

Sleep Apnea; PreDiabetes; Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Intervention

Diet and exercise.

Group Type: OTHER

Diet and exercise coaching

Intervention Type: BEHAVIORAL

All participants will receive diet and exercise goals and coaching.

Lifestyle Plus CPAP Intervention

CPAP treatment, diet and exercise.

Group Type: EXPERIMENTAL

Diet and exercise coaching

Intervention Type: BEHAVIORAL

All participants will receive diet and exercise goals and coaching.

CPAP Treatment

Intervention Type: OTHER

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

Interventions

Diet and exercise coaching

All participants will receive diet and exercise goals and coaching.

Intervention Type: BEHAVIORAL

CPAP Treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esra Tasali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R01DK120312

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB19-1445

Identifier Type: -

Identifier Source: org_study_id