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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 -OAB | Subjects with overactive bladder (OAB) |
| |
| Group 2 - Insomnia | Subjects with insomnia |
| |
| Group 3 - Normal | Normal Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cystometry | Procedure | recording device measuring pressures though catheters placed in bladder and rectum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of voids associated with urgency | During night in sleep lab | |
| Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings | During night in sleep lab | |
| Time from PSG awakening to each void in minutes | During night in sleep lab |
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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
Insomnia subjects
Exclusion Criteria:
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Subjects identified through urology physicians, sleep laboratory physicians and advertising
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham | North Carolina | 27705 | United States |
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| polysomnography | Procedure | recording device measuring sleep activity through electrodes attached to the subject |
|
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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