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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01029015 |
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Date of registration:
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30/11/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01029015 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosis of both OAB and primary insomnia
- Diagnosis of nocturnal polyuria
- Diagnosis of BPH
- BMI >= 34
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bladder Function
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Intervention(s)
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Procedure: cystometry
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Procedure: polysomnography
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Primary Outcome(s)
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Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
[Time Frame: During night in sleep lab]
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Time from PSG awakening to each void in minutes
[Time Frame: During night in sleep lab]
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Number and proportion of voids associated with urgency
[Time Frame: During night in sleep lab]
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Secondary ID(s)
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905-UC-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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