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Completed

NCT Number: NCT01029015

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

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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Key information

Conditions

Bladder Function Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cystometry

Procedure

recording device measuring pressures though catheters placed in bladder and rectum

Polysomnography

Procedure

recording device measuring sleep activity through electrodes attached to the subject

Primary outcomes

  1. Number and proportion of voids associated with urgency

    Time frame: During night in sleep lab

  2. 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

  3. Time from PSG awakening to each void in minutes

    Time frame: During night in sleep lab

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: Nocturia Plt 1

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 9, 2009
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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