Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects

Completed

Conditions studied: Bladder Function

In brief

This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.

Key facts

Study ID: NCT01029015
Run by: Astellas Pharma Inc
People needed: 26
Starts: 2006-11-01
Expected to finish: 2007-07-01
Last updated by the study team: 2011-03-07

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Must not have a urinary tract infection
Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
OAB subjects
OAB symptoms for >= 3 months
Documented detrusor overactivity episodes within 6 months
Insomnia subjects
Diagnosis of chronic primary insomnia
History of > 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months

You may not qualify if…

Diagnosis of both OAB and primary insomnia
Diagnosis of nocturnal polyuria
Diagnosis of BPH
BMI >= 34

Where it is running

Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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