UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001451
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email maru-tkb@umin.ac.jp

Sponsor
Institute Department of General Medicine and Primary care
Tsukuba University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.