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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT05597020
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent form (ICF) prior to any study-mandated procedure.
* Male or female subjects ≥ 55 years old at the time of signing the ICF.
* Insomnia complaints for at least 3 months prior to Visit 1.
* Insomnia Severity Index© (ISI©) score ≥ 13 at Visit 1.
* Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
* Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.
Exclusion Criteria:
* Woman of childbearing potential, pregnant or plans to become pregnant.
* Planned travel across ≥ 3 time zones during study.
* Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (C-SSRS©).
* Regular caffeine consumption after 4 pm.
* Unable to refrain from smoking during the night.
* Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.
* Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia.
* Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
* Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05597020
Study Brief:
Protocol Section:
NCT05597020