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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT05540392
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Prior PC diagnosis
* No evidence of Prostate Cancer
* Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month
Exclusion Criteria:
* \<1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT)
* Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea
* Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome)
* Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia)
* Initiation of new medications for urinary symptoms in the past 4 weeks
* Altered dosing of medications for urinary symptoms in the past 4 weeks
* Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study
* Implanted electronically charged medical device
* Unable to provide consent for himself
* Unwilling to adhere to all study-related procedures
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05540392
Study Brief:
Protocol Section:
NCT05540392