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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

NCT01029015 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2011-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Bladder Function

Interventions

PROCEDURE

cystometry

recording device measuring pressures though catheters placed in bladder and rectum

PROCEDURE

polysomnography

recording device measuring sleep activity through electrodes attached to the subject

Sponsors & Collaborators

Principal Investigators

  • Use Central Contact · Duke University

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029015 on ClinicalTrials.gov