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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT05233800
Eligibility Criteria:
Inclusion Criteria:
* Willingness to maintain a consistent dosing pattern if currently taking sleep medications or using cannabis for sleep
* Females; Age 18+
* Self-reported or documented diagnosis of breast cancer stage I-III or stage IV ECOG 0-1
* Completed curative treatment (surgery, radiation, chemotherapy) \> 3 months prior to enrollment \[ongoing adjuvant therapy permitted\]
* Has not undergone other behavioral sleep treatment within the prior 12 months
* Score greater than or equal to 8 on the Insomnia Severity Index
* Able to understand and speak English
Exclusion Criteria:
* Diagnosed, untreated obstructive sleep apnea syndrome, narcolepsy, restless leg syndrome, periodic limb movement disorder, delayed sleep phase syndrome, central apnea
* Bi-polar disorder, schizophrenia, initiation of psychological treatment within three months, alcohol or drug abuse in the prior year (Alcohol \>2 drinks/day or consuming 5+ drinks in a single day in the prior month). (Moderate ADHD, depression and anxiety will not be exclusion criteria.)
* Shift-work in the prior three months or anticipated during the study time
* Planned regular travel out of time zone (\>1 hour) during the study period.
* Currently or planning to become pregnant during the study period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05233800
Study Brief:
Protocol Section:
NCT05233800