UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029267 |
|---|---|
| Receipt number | R000033452 |
| Scientific Title | Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2019/10/21 16:55:31 |
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Basic information
Public title
Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure
Acronym
Sleep Apnea, CPAP and Intraocular Pressure
Scientific Title
Effects of Sleep Apnea and Continuous Positive Pressure Breathing on Intraocular Pressure
Scientific Title:Acronym
Sleep Apnea, CPAP and Intraocular Pressure
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of CPAP on intraocular pressure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences of the intraocular pressure among the groups with and without CPAP therapy.
Key secondary outcomes
1: Differences of intraocular pressure before and after the CPAP therapy
2: Differences of the following parameters between before and after CPAP theapy.
Parameters of the polysomnography
Hemodynamic parameters
Circumferences of the neck and the lowe leg
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CPAP treatment during the last half of 7 hours night sleep.
Interventions/Control_2
No CPAP treatment as a control
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criterias
1: ODI3%>= 20
2: 17<= BMI <40
Key exclusion criteria
Patients who meet one of the following criterias are excluded.
1:Patients with severe heart failure
2:Patients with severe respiratory failure
3:Patients with dementia
4:Patients with severe sleep disease other than SAS
5:Patients with some significant disease which influence CPAP therapy
6:Patients with significant eye disease other than glaucoma
7:Patients whose docter in charge do not agree to join this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takero Fukutome |
Organization
Fukuoka Sleep Clinic
Division name
Fukuoka Sleep Clinic
Zip code
Address
Chambord B 1301, Chyuoku 2-10--2, Fukuoka City
TEL
092-400-2007
fukuoka_suimin@aurora.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takero Fukutome |
Organization
Fukuoka Sleep Clinic
Division name
Fukuoka Sleep Clinic
Zip code
Address
Chambord B 1301, Chyuoku 2-10--2, Fukuoka City
TEL
092-400-2007
Homepage URL
fukuoka_suimin@aurora.ocn.ne.jp
Sponsor or person
Institute
Fukuoka Sleep Clinic
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Sleep Clinic
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
| 2017 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Data was obtained from 28 subjects
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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 24 | Day |
Last modified on
| 2019 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033452
