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
CRIS Registration Number |
KCT0001223 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ferring pharmaceuticals Korea |
Organization Type | Pharmaceutical Company |
Project ID | GAIRB2014-17 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Ferring pharmaceuticals Korea |
Organization Type | Pharmaceutical Company |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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
Condition(s)/Problem(s) |
* (Z00-Z99)Factors influencing health status and contact with health services (Z57.8)Occupational exposure to other risk-factors |
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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 |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | voiding diary |
|
Timepoint | before night work shift date, just after work shift, and 12 day after work shift |
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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 |
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Primary Outcome(s) 3 | ||
Outcome | PSQI-K: Pittsburgh Sleep Quality Index Korean |
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Timepoint | before night work shift date, just after work shift, and 12 day after work shift |
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Primary Outcome(s) 4 | ||
Outcome | KESS: Korean version of the Epworth Sleepiness Scale |
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Timepoint | before night work shift date, just after work shift, and 12 day after work shift |
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Secondary Outcome(s) 1 | ||
Outcome | BSW ( Benefit, satisfaction, willingness) |
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Timepoint | Final research day |
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Secondary Outcome(s) 2 | ||
Outcome | Initial sleep time/ Total sleep time |
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Timepoint | before and after research |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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