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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT01011218
Eligibility Criteria:
INCLUSION CRITERIA
* Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
* Have at least 6 weeks of treatment remaining
* ≥ 21 years old
* Able to understand written and spoken English
* Able to swallow medication (until amendment omitting armodafinil treatment)
* Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)
EXCLUSION CRITERIA
* Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
* Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
* Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
* Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
* History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
* History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
* Pregnant or nursing
* History of substance abuse or meet criteria for current alcohol abuse or dependence
* History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
* Severe hepatic impairment (until amendment omitting armodafinil treatment)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01011218
Study Brief:
Protocol Section:
NCT01011218