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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00631657
Eligibility Criteria:
Inclusion Criteria:
* are at least 18 and less than 65 years;
* sign written informed consent after the scope and nature of the investigation have been explained;
* have shown capability to complete the LogPad questionnaires;
* have difficulty falling asleep, maintaining sleep or have early morning awakening;
Exclusion Criteria:
* Significant medical or psychiatric illness causing sleep disturbances.
* Have a history of bipolar disorder or attempted suicide or have a family (immediate family) history of suicide.
* Have a sleep disorder such as sleep-related breathing disorder, restless leg syndrome, narcolepsy.
* Significant other medical illness such as acute or chronic pain, heart-, kidney-, or liver disease within the last year.
* Currently diagnosed or meet the criteria for Major Depressive Disorder (MDD) or have been treated for MDD in the last 2 years.
* Substance abuse, excessive use of alcohol (determined by the physician) or drug addiction within the last year.
* Are night workers or rotating shift workers or plan to travel through more than 3 time-zones.
* Routinely nap during the day.
* Have a Body Mass Index (BMI) of 36 or more.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00631657
Study Brief:
Protocol Section:
NCT00631657