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Technology-Supported Treatment of Sleep Apnea in Prediabetes

Study acronym: TECH
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Minor Trial completed
    • Enrollment target: estimated 174 to confirmed 182
    • Primary and study completion dates changed from estimate of Jul 2026 to Jul 31, 2026
    • Eligibility criteria expanded, about 6 words
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v17
  4. Minor Re-verified, no change to tracked fieldsv16
  5. Minor Primary completion date: Feb 2026 to Jul 2026
    • Site contact updated
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Minor Primary completion date: Dec 31, 2025 to Feb 2026
    • Study completion date: Dec 31, 2025 to Jul 2026
    • Site contact updated
    v14
  2. Minor 2 versions Re-verified since Aug 8, 2024, no change to tracked fieldsv12-v13
  3. Notable Enrollment target: 740 to 174v11
  4. Minor Primary and study completion dates: Jul 31, 2025 to Dec 31, 2025v10
  5. Minor Re-verified, no change to tracked fieldsv9
  6. Notable Primary endpoints: 2 to 1
    • Secondary endpoint revised
    v8
  7. Minor Secondary endpoints: 2 to 1v7
  8. Notable Primary and study completion dates: Jul 31, 2024 to Jul 31, 2025
    • Start date: Nov 1, 2020 to Apr 13, 2021
    v6
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  10. Notable Start date: Jul 1, 2020 to Nov 1, 2020v4
  11. Notable Start date: Apr 1, 2020 to Jul 1, 2020v3
  12. Notable Start date: Feb 1, 2020 to Apr 1, 2020v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT04225507
Lead Sponsor University of Chicago
Collaborators: Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Sleep Apnea, PreDiabetes, Overweight or Obesity
Related terms Obesity, Overweight, Prediabetic State, Sleep Apnea Syndromes
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov