Technology-Supported Treatment of Sleep Apnea in Prediabetes (TECH)
Primary Purpose
Sleep Apnea, PreDiabetes, Overweight or Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and exercise coaching
CPAP Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
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
Sites / Locations
- University of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Lifestyle Intervention
Lifestyle Plus CPAP Intervention
Arm Description
Diet and exercise.
CPAP treatment, diet and exercise.
Outcomes
Primary Outcome Measures
Change from baseline 2-hour glucose levels at 6 months
Glucose levels will be measured at time=120min during oral glucose tolerance test
Secondary Outcome Measures
Change from baseline morning blood pressure at 6 months
Morning blood pressure will be measured with a blood pressure cuff while sitting
Full Information
NCT ID
NCT04225507
First Posted
January 7, 2020
Last Updated
May 3, 2023
Sponsor
University of Chicago
Collaborators
Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04225507
Brief Title
Technology-Supported Treatment of Sleep Apnea in Prediabetes
Acronym
TECH
Official Title
Technology-Supported Treatment of Sleep Apnea in Prediabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, PreDiabetes, Overweight or Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
740 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Other
Arm Description
Diet and exercise.
Arm Title
Lifestyle Plus CPAP Intervention
Arm Type
Experimental
Arm Description
CPAP treatment, diet and exercise.
Intervention Type
Behavioral
Intervention Name(s)
Diet and exercise coaching
Intervention Description
All participants will receive diet and exercise goals and coaching.
Intervention Type
Other
Intervention Name(s)
CPAP Treatment
Intervention Description
CPAP treatment for sleep apnea and CPAP education and adherence coaching.
Primary Outcome Measure Information:
Title
Change from baseline 2-hour glucose levels at 6 months
Description
Glucose levels will be measured at time=120min during oral glucose tolerance test
Time Frame
Baseline and at 6 months
Secondary Outcome Measure Information:
Title
Change from baseline morning blood pressure at 6 months
Description
Morning blood pressure will be measured with a blood pressure cuff while sitting
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Millie Maleckar
Phone
773-702-6505
Email
mmalecka@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Esra Tasali, MD
12. IPD Sharing Statement
Learn more about this trial
Technology-Supported Treatment of Sleep Apnea in Prediabetes
We'll reach out to this number within 24 hrs