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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01530451
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female patient (aged\</=65 years old)
* Obstructive sleep apnoea diagnosed by sleep study
* Stable treatment on obstructive sleep apnoea and / or LUTS
* Nocturia on average more than once per night
* Having the ability to communicate and comply with the requirements of the study
Exclusion Criteria:
* Presence of urethral strictures and neurogenic bladder dysfunction
* Clinical evidence of bladder stones, bladder tumor or an active urinary tract infection
* History of prostate cancer or prostate specific antigen (PSA) level \> 10ng/ml or suspicious of prostate cancer on digital rectal examination (DRE), unless a transrectal biopsy of prostate has been performed and the presence of prostate cancer has been excluded.
* Patient on intermittent self-catheterisation
* Recent start or change of treatment on obstructive sleep apnoea and / or nocturia
* Uncontrolled medical problems: e.g. Diabetes Mellitus or Diabetes insipidus
* Hyponatraemia
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01530451
Study Brief:
Protocol Section:
NCT01530451