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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT00177203
Eligibility Criteria:
Inclusion Criteria:
* Age 60 or older
* Current diagnosis of Insomnia using DSM-IV criteria (Insomnia group)
* No current diagnosis of Insomnia (Control group)
* Provision of written informed consent
Exclusion Criteria:
* Psychiatric: untreated depressive, anxiety, psychotic and substance use disorders and/or treated or untreated delirium of dementia. We will exclude at intake to the study any individual with moderate to severe cognitive impairment who is likely to be demented. In the event that an individual scores less than \< 25 on the Mini-Mental State Exam, we will exclude that person from the study. We will also discuss our concerns with the subject and will suggest that he or she contact the Memory Disorders Clinic run by the Alzheimer's Disease Research Center. We will give the subject literature on this Clinic as well as their phone number. We will not exclude persons with milder cognitive decrements because chronic medical disease and its associated sleep disruption are themselves associated with some impairment of cognitive performance.
* Medical: ongoing chemotherapy or radiation cancer treatment, hospitalization within the past two weeks or terminal illness with a life expectancy less than 6 months;
* Sleep: untreated obstructive sleep apnea syndrome, narcolepsy or restless legs syndrome.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00177203
Study Brief:
Protocol Section:
NCT00177203