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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04576260
Eligibility Criteria:
Inclusion Criteria:
* BMI above 25kg/m2.
* Self-reported sleep of \<7hrs (confirmed through actigraphy).
* A global score of \>5 on the Pittsburgh Sleep Quality Index (PSQI)
* Participants on any kind of self-prescribed or over the counter medication for sleep, will be included in the study after a two-week interval for elimination drug from the system.
Exclusion Criteria:
* Presence of sleep-related disorders measured through the Sleep Disorder Symptoms Checklist (SDSCL-25)
* Any serious medical conditions which might influence sleep i.e. cardiovascular diseases, diabetes, cancer, respiratory disease, other than mild asthma.
* History of bariatric surgery.
* Taking any kind of prescribed hypnotics or sleep medication
* Taking any kind of medication which might affect appetite
* Participating in any kind of dietary and/or weight loss programs
* Taking Antidepressants
* Substance or alcohol abuse
* Shift work
* Currently having to wake up at night to care for another person
* Suffering from and/or receiving treatment for a mental health conditions or sleep apnea.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT04576260
Study Brief:
Protocol Section:
NCT04576260