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The effect of minirin® on sleeping and voiding pattern to whom circadian rhythmic changed work-shift nurses

Status Approved

  • First Submitted Date

    2014/07/04

  • Registered Date

    2014/09/15

  • Last Updated Date

    2014/09/04

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0001223
    Unique Protocol ID GAIRB2014-17
    Public/Brief Title The effect of minirin® on sleeping and voiding pattern to whom circadian rhythmic changed work-shift nurses
    Scientific Title The effect of minirin® on sleeping and voiding pattern to whom circadian rhythmic changed work-shift nurses
    Acronym The effect of minirin® on sleeping and voiding pattern to whom circadian rhythmic changed work-shift nurses
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number GAIRB2014-17
    Approval Date 2014-02-19
    Institutional Review Board Name Gachon University Gil Medical center institutional review board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Kyung Jin Chung
    Title Assistant Professor
    Telephone +82-32-460-3334
    Affiliation Gachon University Gil Medical Center
    Address
    Contact Person for Public Queries
    Name Kyung Jin Chung
    Title Assistant Professor
    Telephone +82-32-460-3334
    Affiliation Gachon University Gil Medical Center
    Address
    Contact Person for Updating Information
    Name Chang hee Kim
    Title Clinical and Researc
    Telephone +82-32-460-3334
    Affiliation Gachon University Gil Medical Center
    Address
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2014-04-28 Actual
    Target Number of Participant 34
    Primary Completion Date 2015-08-17 , Anticipated
    Study Completion Date 2015-08-17 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Gachon University Gil Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2014-04-28 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ferring pharmaceuticals Korea
    Organization Type Pharmaceutical Company
    Project ID GAIRB2014-17
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Ferring pharmaceuticals Korea
    Organization Type Pharmaceutical Company
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The increasing number of night shift jobs and workers is inevitable in our modern complex society. Such shift-work can affect the sleep/wake cycle by disrupting the synchronous relationship between the natural circadian rhythm of the body and the environment. A disrupted circadian rhythm disturbs homeostasis, which leads to the development of many types of metabolic disorders. Our previous study (in submission to Neurourol & Urodynamics, supported by Ferring Pharmaceuticals) reveals new insights on the effect of circadian rhythmic change on micturition. We found out that although urine volume-related parameters increased with circadian rhythm disruption. This suggests the possibility that the urinary bladder adjusts urgency and frequency according to the change in urinary volume due to work-shift rotation. We make hypothesis that fragmented sleep is a kinds of abnormal sleep pattern and this might be due to urination during the daytime sleep, so to speak, extreme form of nocturia during daytime according to night time work. This pattern of sleep fragmentation might have bad effect on sleep and might give a bad effect to general health state if this life patterns are persisted. Minirin® (Desmopressin acetate) is a synergic analog of ADH, a hormone that works to increase water absorption and decrease urine output. Therefore, Likewise its action to nocturia, it also might reduce the urination during daytime sleep. Accordingly this might affect the sleep/wake cycle by reducing fragmented sleep from disrupting the synchronous relationship to help return to the natural circadian rhythm of the body easily. We plan to investigate the effect of minirin® on voiding pattern and sleeping pattern of nurse as a representative rotation shift worker during their work shift schedule. This study could give more understanding about circadian rhythm and give some recognition about the effect of acute circadian rhythmic change to voiding pattern. Furthermore, we expect this result might give us some clue about the new efficacy of minirin® in relation with circadian rhythmic change.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description
    The primary assessment criteria will be the change between baseline and after minirin® administration in sleep pattern and voiding pattern during 10 days of work shift duty. Orally ingest minirin® 1mg once daily for 3 days before making asleep a day after night duty-on.
    Number of Arms 1
    Arm 1

    Arm Label

    Circadian rhythmic changed work-shift nurses who administrated minirin®

    Target Number of Participant

    34

    Arm Type

    Experimental

    Arm Description

    The primary assessment criteria will be the change between baseline and after minirin® administration in sleep pattern and voiding pattern during 10 days of work shift duty. Orally ingest minirin® 1mg once daily for 3 days before making asleep a day after night duty-on. The subject will be invited to record the assessment questionnaire before night work shift date, just after work shift, and 12 day after work shift. The assessment questionnaire includes voiding diary [for voiding volume, urine volume during sleep (adopted from the definition of nocturnal urine volume (NUV)), functional bladder capacity (FBC), sleeping urination index (adopted from the definition of nocturia index (NI); Urine volume during sleep/ FBC), and Overactive Bladder Symptom Score (OABSS). 
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (Z00-Z99)Factors influencing health status and contact with health services 
       (Z57.8)Occupational exposure to other risk-factors 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~50Year

    Description

    1) Female nurse at the age of 20 ~ 50 who assigned to the general ward and sifted to the nigh duty
    2) A woman without any LUTS 
    3) A woman who has given written informed consent from voluntarily before any trial related actives 
    
    Exclusion Criteria
    1) A woman who has history of urinary tract infections within one month.
    2) A woman who has been treated with alpha-blocker, anticholinergic, cholinergic, diuretic for more than three months.
    3) A woman who is during her menstrual period
    4) A woman who is pregnant or is under breast feeding
    5) A woman who has history of SIADH
    6) A woman who has nocturnal polyuria, hypertention, chronic renal disease, or cardiovascular disease
    7) A woman who has habitual or psychotic polydypsia (24 hrs urine output > 40ml/kg) 
    8) A woman who has history of chronic pelvic pain syndrome.
    9) A woman who has history of cancer in abdominal or endopelvis.
    10) A woman who treated with pelvic radiation therapy.
    11) A woman who received transurethral resection (TUR).
    12) A woman diagnosed with interstitial cystitis.
    13) A woman who be considered unacceptable by investigator.
    
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    voiding diary 
    Timepoint
    before night work shift date, just after work shift, and 12 day after work shift
    Primary Outcome(s) 2
    Outcome
    OABSS: overactive bladder symptom score
    Timepoint
    before night work shift date, just after work shift, and 12 day after work shift
    Primary Outcome(s) 3
    Outcome
    PSQI-K: Pittsburgh Sleep Quality Index Korean
    Timepoint
    before night work shift date, just after work shift, and 12 day after work shift
    Primary Outcome(s) 4
    Outcome
    KESS: Korean version of the Epworth Sleepiness Scale
    Timepoint
    before night work shift date, just after work shift, and 12 day after work shift
    Secondary Outcome(s) 1
    Outcome
    BSW ( Benefit, satisfaction, willingness) 
    Timepoint
    Final research day 
    Secondary Outcome(s) 2
    Outcome
    Initial sleep time/ Total sleep time
    Timepoint
    before and after research 
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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