UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001451 |
|---|---|
| Receipt number | R000001621 |
| Scientific Title | Prevalance of the sleep apnea syndrome in fatigue patients,cross-sectional, observational study |
| Date of disclosure of the study information | 2008/10/22 |
| Last modified on | 2013/10/05 11:35:55 |
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Basic information
Public title
Prevalance of the sleep apnea syndrome in fatigue patients,cross-sectional, observational study
Acronym
Prevalance of the sleep apnea syndrome in fatigue patients
Scientific Title
Prevalance of the sleep apnea syndrome in fatigue patients,cross-sectional, observational study
Scientific Title:Acronym
Prevalance of the sleep apnea syndrome in fatigue patients
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Medicine in general | Pneumology | Psychiatry |
| Oto-rhino-laryngology | Oral surgery | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalance of sleep apnea syndrome in fatigue patients
Basic objectives2
Others
Basic objectives -Others
prevalance
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalance of sleep apnea syndrome in fatigue patients.
The diagnosis of sleep apnea syndrome is made by portable oxgen saturation monitor.The diagnostic criteria for sleep apnea syndrome is as follows;The number of the event that their oxgen saturation levels are below 3% or less than their baseline saturation levels are 15 times or more in an hour(positive likelihood ratio 5.1,negative likelihood ratio 0.54 to the diagnosis of sleep apnea syndrome by polysomnography).
The prevalance of sleep apnea syndrome is defined as the number of included patient diagnosed as sleep apnea syndrome devided by the number of patient those who visited office for the first time with complaint of persistent fatigue .
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20-year-old or more those who visited the out-patient office of the department of general medicine and primary care in Tsukuba medical center hospital for the first time with any complaint of persistant fatigue(which lasts for 1 month or more) on the ICPC-2-based-questionaire.
We do not exclude patients as follows
;Patients with diagnosis of sleep apnea syndrome, hypertension, diabetes, obesity or depression.
Key exclusion criteria
We exclude the patients who are not
capable of replying and writing to fill inquiry owing to dementia,visual disorder and so on (The office physician is in charge of the decision to exclude).
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Ishimaru |
Organization
Tsukuba Medical Center Hospital
Division name
Department of General Medicine and Primary care
Zip code
Address
Amakubo1-3-1 Tsukuba city,Ibaraki
TEL
029-851-3511
maru-tkb@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Ishimaru |
Organization
Tsukuba Medical Center Hospital
Division name
Department of General Medicine and Primary care
Zip code
Address
Amakubo 1-3-1, Tsukuba City, Ibaraki
TEL
029-851-3511
Homepage URL
maru-tkb@umin.ac.jp
Sponsor or person
Institute
Department of General Medicine and Primary care
Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Academy of Family Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
筑波メディカルセンター病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/general/13/2/13_103/_pdf
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Relationship between the observed factors and the results
Major result of this study
Survey on the prevalence of sleep apnea syndrome
The diagnosis of sleep apnea syndrome is made by home portable O2 Saturation monitor(PULSOX;-Me300,Teijin);Patients with 15 times or more desaturation events are diagnosed as sleep apnea syndrome.
Desaturation event is defined as the event more than 3% decrease of O2saturation level from the patients baseline level.
the prevalence of sleep apnea syndrome
=the numbers of sleep apnea syndrome patients among included patients/the numbers of patients who visited our first visit office with persistant fatigue.
Results from subgroup analysis
;After data entry,we review the relationship between this disease and observed factors by multiple variables analysis.
Observed factors include the length of fatigue,JESS(Japanese version of Epworth Sleepiness Scale),history of depression(5 or more point in DSM-4 major depression episode),BMI,hypertension,diabetes and neck circumference.
Management information
Registered date
| 2008 | Year | 10 | Month | 22 | Day |
Last modified on
| 2013 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001621
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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