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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05747105
Eligibility Criteria:
Inclusion Criteria:
1. Adults, aged 18-50 years old,
2. All genders
3. Body Mass Index within the obese weight status (BMI of ≥ 30 kg/m2)
4. Short sleep duration, defined as sleeping, on average, \<6.5 hours/night for at least 5 nights/week
5. Sleep patterns must be stable for the past 6 months
6. Weight must be stable (+/- 10 lb) for the past 6 months
7. If taking medication for medical or mental health conditions, the condition must be well-controlled with stable dosage (i.e., at least 3 months)
8. Note: Individuals with and without insomnia will be eligible to participate to increase generalizability of the findings. Also, individuals with known obstructive sleep apnea that is being treated and individuals who fall below the "very high risk" category for obstructive sleep apnea (on the ARES screening questionnaire) will be included.
9. Participants must provide a completed form for study participation from their primary care provider to confirm that it is safe from a medical perspective
Exclusion Criteria:
1. Specific chronic sleep disorders (e.g., untreated or at very high risk for obstructive sleep apnea, restless leg syndrome, parasomnias, narcolepsy, central apnea, chronic fatigue syndrome, or fibromyalgia)
2. Extreme chronotype (i.e., extreme morning or evening sleep patterns)
3. Work schedule that is not compatible with sleep habit changes (e.g., night shifts, rotating shift work, or long driving)
4. Chronic use of sleep aid or anticonvulsant medications
5. Chronic organ disorders (e.g., untreated or uncontrolled diabetes, other endocrine disorders, COPD, chronic cardiac arrhythmia, uncontrolled hypertension or gastro-esophageal disorders)
6. Current enrollment in a weight loss program or any active weight loss attempt (e.g., self-directed diet/exercise, over-the-counter supplements, weight management medication)
7. History of bariatric surgery (with the exception of an adjustable gastric band that has been removed)
8. Mental health disorders judged severe (e.g., major depression, eating disorders, anxiety disorders, bipolar disorder/mania, schizophrenia, active suicidal ideation)
9. Substance use (e.g., illicit drugs, marijuana dependence, excessive caffeine intake, smoking/tobacco use)
10. Planned move outside of the Philadelphia area in the next 6 months
11. Planned travel across time zones during the study period
12. Family factors that may interfere with adherence to the study protocol (e.g., infants and young children that consistently disrupt their sleep schedule; partner, other individuals, or pets that would make compliance difficult)
13. Pregnancy or lactation or plans to become pregnant during the study period
14. Menopause
15. Any other contraindication to participation as determined by the study team
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05747105
Study Brief:
Protocol Section:
NCT05747105