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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00097604
Eligibility Criteria:
Inclusion Criteria:
* Pittsburgh Sleep Quality Instrument score higher than 5
* Insomnia Severity Index score less than 22
* At least 5 years past menopause, for female participants
Exclusion Criteria:
* Current use of prescribed or over-the-counter sleep medications
* Plans to move from the area within 2 months of study entry
* Significant signs and symptoms of sleep apnea; periodic leg movements in sleep (PLMS) associated with arousals; rapid eye movement (REM) behavior disorder; restless legs syndrome; advanced sleep phase syndrome; delayed sleep phase syndrome; or any other sleep disorder, including severe insomnia or a history of chronic insomnia, for which standard therapy would be the treatment of choice
* Shift work within 6 months prior to study entry
* Current unusual or highly unstable sleep schedule
* Trans-meridian travel across more than three time zones within 4 weeks prior to study entry
* Body mass index between 18 kg/m2 and 32 kg/m2
* Significant and uncontrolled major illness or psychiatric disease
* Cognitive impairment
* Current life stress
* Use of tobacco within 6 months prior to study entry
* Excessive use of alcohol or caffeine
* Currently taking hormone replacement therapy hypnotic or psychotropic medication
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT00097604
Study Brief:
Protocol Section:
NCT00097604