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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02552303
Eligibility Criteria:
Inclusion Criteria:
* eligible subjects must have begun their CPAP treatment within the last 3 months
* current ESS (Sleepiness) Scores between 5-19
* no history of upper airway surgery (e.g. UPPP)
* able to understand written and spoken English
* able to swallow medication
* preferred sleep phase between 9:00 pm and 9:00 am
* willing to discontinue any sleep medications/over-the-counters(OTCs)/Herbals for insomnia for the 11-week study period.
* female participants must not be pregnant or breastfeeding and must agree to use two forms of birth control during the study period, as Armodafinil may interfere with hormonal birth control.
* all participants will be asked to postpone any additional or alternate treatments for their Obstructive Sleep Apnea (OSA) until after the completion of their participation in this research study.
* for other elective procedures, prospective participants are recommended to either postpone the procedure until after completion of their participation in this study, or alternatively to start the study after completion of the elective procedure.
Exclusion Criteria:
* CPAP usage exceeding three months prior to pre-screening
* suicide attempts within the last five years
* unstable medical or psychiatric illness
* cardiac abnormalities, liver, or kidney diseases
* sleep disorders other than insomnia or SDB
* evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
* use of central nervous system (CNS) active medications, antidepressants and hypnotics prescribed as sleep-aids (these medications are permitted if prescribed for mediation of symptoms other than sleep and the patient has been on a stable dosage for a minimum of one month, with no anticipation of altering their dosage during the study period.)
* inadequate language comprehension
* pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02552303
Study Brief:
Protocol Section:
NCT02552303