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 (Nocturia Plt 1)
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Details and patient eligibility
About
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.
Enrollment
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Inclusion criteria
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Must not have a urinary tract infection
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Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
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Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
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OAB subjects
- OAB symptoms for >= 3 months
- Documented detrusor overactivity episodes within 6 months
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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
Exclusion criteria
- Diagnosis of both OAB and primary insomnia
- Diagnosis of nocturnal polyuria
- Diagnosis of BPH
- BMI >= 34
Trial design
26 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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