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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03594994
Eligibility Criteria:
Inclusion Criteria:
* Sleep \<7h/night
* Body mass index 25-50 kg/m2
* Altered glucose metabolism (any of the following) Fasting glucose 100-125 mg/dL or, 2-h plasma glucose 140-199 mg/dL during an oral glucose tolerance test (OGTT) or, HbA1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (HOMA-IR) ≥2.0
Exclusion Criteria:
* Sleep disorders
1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour)
2. had ≥15 periodic limb movements per hour sleep \[PLMS\]
3. narcolepsy or insomnia
* Perform shift work
* Excessive caffeine or alcohol consumption
* Significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease)
* Liver disease other than metabolic dysfunction associated steatotic liver disease (MASLD)
* Prior bariatric surgery
* Pregnancy or breastfeeding
* Taking medications that can affect study outcomes (alter sleep duration or glucose metabolism)
* Tobacco or illicit drug use
* Perform intense exercise \>70 min/wk or moderate exercise \>150 min/week
* Excessive alcohol consumption (\>21 units of alcohol per week for men and \>14 units of alcohol per week for women)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03594994
Study Brief:
Protocol Section:
NCT03594994