UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032953 |
|---|---|
| Receipt number | R000036674 |
| Scientific Title | Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level. |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/12 05:26:16 |
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Basic information
Public title
Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Acronym
Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Scientific Title
Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Scientific Title:Acronym
Investigation on effects of sleep apnea syndrome (SAS) and its CPAP treatment on serum KL-6 level.
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between Sleep apnea syndrome(SAS) and serum KL-6 level and the effect of Positive Airway Pressure treatment (CPAP) on its levels.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between sleep apnea syndrome(SAS) and serum KL-6 level, and the effect of CPAP treatment on its level 6 months after the start of treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Positive Airway Pressure treatment (CPAP) for 6 months
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
| 10 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with sleep apnea syndrome who first visit a sleep clinic at our university hospital.
2)Patients with informed concent.
Key exclusion criteria
1)Patients with interstitial lung disease
2)Patients with hypoxemia (at awake resting SpO 2 <95%)
3)Patients with infectious pneumonia or drug pneumonia or advanced stage cancer or pulmonary tuberculosis or alveolar proteinosis.
4)Patients in a state of shock
5)Patients with disturbance of consciouness
6)Patients on a ventilator
7)patients who are cnsiderded unsuitable for the trial by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenjirou Wasano |
Organization
Kurume University school of medicine
Division name
Depertment of Neuropsychiatry
Zip code
Address
67 Asahi-machi,Kurume,Fukuoka,Japan
TEL
+81-942-31-7564
wasano_kenjirou@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjirou Wasano |
Organization
Kurume University school of medicine
Division name
Depertment of Neuropsychiatry
Zip code
Address
67 Asahi-machi,Kurume,Fukuoka,Japan
TEL
+81-942-31-7564
Homepage URL
wasano_kenjirou@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University school of medicine,Depertment of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Kurume University school of medicine,Depertment of Neuropsychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036674
