Sleep ApneaTECHNCT04225507
Technology-Supported Treatment of Sleep Apnea in Prediabetes
A study testing Diet and exercise coaching and CPAP Treatment in people with Sleep Apnea and PreDiabetes, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Sleep Apnea, PreDiabetes, Overweight or Obesity
- What is being tested?
- Diet and exercise coaching and CPAP Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese
- Prediabetes
- Sleep apnea
Who cannot join
- Diabetic
- enrolled in a formal weight loss program
- Any underlying disease likely to limit life span and/or increase risk of interventions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Diet and exercise coaching, CPAP Treatment
- Medical subject headings
- Sleep Apnea Syndromes, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exercise coachingBehavioural
All participants will receive diet and exercise goals and coaching.
CPAP TreatmentOther
CPAP treatment for sleep apnea and CPAP education and adherence coaching.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Other | Diet and exercise. Receives: Behavioral: Diet and exercise coaching |
| Lifestyle Plus CPAP Intervention | Experimental | CPAP treatment, diet and exercise. Receives: Behavioral: Diet and exercise coaching; Other: CPAP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 2-hour glucose levels at 6 months
Glucose levels will be measured at time=120min during oral glucose tolerance test
Measured: Baseline and at 6 months
Secondary outcomes (1)
Change from baseline morning blood pressure at 6 months
Morning blood pressure will be measured with a blood pressure cuff while sitting
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Apr 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225507
- Sponsor's protocol ID
- IRB19-1445
- Other IDs
- R01DK120312
- Acronym
- TECH
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Supported Treatment of Sleep Apnea in Prediabetes
- ClinicalTrials.gov ID
- NCT04225507
- Acronym / sponsor ID
- TECH / IRB19-1445
- Conditions
- Sleep Apnea, PreDiabetes, Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Other | Behavioral: Diet and exercise coachingDiet and exercise. |
| Lifestyle Plus CPAP Intervention | Experimental | Behavioral: Diet and exercise coaching, Other: CPAP TreatmentCPAP treatment, diet and exercise. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obese
- Prediabetes
- Sleep apnea
Key exclusion criteria (3 listed)
- Diabetic
- enrolled in a formal weight loss program
- Any underlying disease likely to limit life span and/or increase risk of interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and exercise coachingAll participants will receive diet and exercise goals and coaching. | Behavioural | Lifestyle Intervention, Lifestyle Plus CPAP Intervention |
| CPAP TreatmentCPAP treatment for sleep apnea and CPAP education and adherence coaching. | Other | Lifestyle Plus CPAP Intervention |
Primary outcome
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
1 secondary outcome
Change from baseline morning blood pressure at 6 months
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Tasali, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise coaching and CPAP Treatment in people with Sleep Apnea and PreDiabetes, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline 2-hour glucose levels at 6 months (time frame: Baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.