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:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01163032
Eligibility Criteria:
Inclusion Criteria:
* Ability and acceptance to provide informed consent;
* No perception of light by the subject's own report;
* Diagnosis of N24HSWD as determined by:
1. History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
2. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
* Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
* Fluent in English;
Exclusion Criteria:
* Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
* Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
* History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
* History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
* Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
* Unable to perform calls to the study IVR system to report questionnaire results;
* Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;
* Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle
* Use of melatonin or melatonin agonist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01163032
Study Brief:
Protocol Section:
NCT01163032