Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT03984058
Eligibility Criteria:
Inclusion Criteria:
* Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
* Moderate-to-severe OSA \[4% oxygen desaturation index (ODI) ≥ 20/h\]
* Ability to provide informed consent
* Able to comply with all study procedures and be available for the study duration
* Availability of smart phone
Exclusion Criteria:
* BMI \< 28 or ≥ 38 kg/m2
* Type 1 or Type 2 diabetes mellitus
* Pregnancy
* Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
* Prior or anticipated bariatric surgery
* Current use of PAP or oral appliance therapy for OSA
* Commercial driver
* Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
* Epworth Sleepiness Scale score10 \> 18
* Current (prevalent) use of oral corticosteroids (within 1 month)
* Participation in a concurrent clinical trial
* Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension \[BP ≥ 160/100 among those with hypertension, requiring 3 or more meds\], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
* Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns \< 5 hrs/night)
* Use of supplemental oxygen during wakefulness or sleep
* Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (\> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 \< 90%
* Chronic opiate use.
* Use of illicit drug / marijuana use more than once per week
* Difficulty understanding or speaking English
* Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03984058
Study Brief:
Protocol Section:
NCT03984058