UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026368 |
|---|---|
| Receipt number | R000029836 |
| Scientific Title | The study of sleep apnea syndrome with nasal obstruction |
| Date of disclosure of the study information | 2017/03/02 |
| Last modified on | 2017/03/08 11:38:34 |
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Basic information
Public title
The study of sleep apnea syndrome with nasal obstruction
Acronym
The study of nasal obstruction
Scientific Title
The study of sleep apnea syndrome with nasal obstruction
Scientific Title:Acronym
The study of nasal obstruction
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Pneumology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nasal obstruction frequently has been associated with worsening the treatment for sleep apnea syndrome(SAS). We examined the two types of treatment for allergic rhinitis with SAS, and in a future this study will be useful for nasal obstruction of SAS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The chages of nasal obstruction in patients with OSAS after treatment
2.Serum total IgE, RAST
3.The persistence of CPAP treatment (using time etc.)
4.The questionnaire of Pittsburg Sleep Quality Index(PSQI)
5.Epworth sleepness scale(ESS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The following each treatment for 14days
1.Fexofenadine Hydrochloride(60mg) twice daily
Interventions/Control_2
2.Fexofenadine Hydrochloride(60mg)/ Pseudiephedrine Hydrochloride(120mg) Combination Tablets twice daily
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who diagnosed with SAS and started CPAP therapy have nasal obstruction for allergic rhinitis.
Key exclusion criteria
severe nasal septal space disease
severe nasal polyps
severe nasal tumor
Uncontrolled hypertension
Severe coronary artery disease
Narrow angle glaucoma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Fukunaga |
Organization
Department of Medicine, Keio University School of Medicine
Division name
Pulmonary Medicine
Zip code
Address
35 shinanomochi shinjyuku-ku, Tokyo, JAPAN
TEL
0333531211
k-fuku@jf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakako Yamasawa |
Organization
Department of Medicine, Keio University School of Medicine
Division name
Pulmonary Medicine
Zip code
Address
35 shinanomochi shinjyuku-ku, Tokyo, JAPAN
TEL
0333531211
Homepage URL
http://www.keio-med.jp/pulmonary/
wakako@df6.so-net.ne.jp
Sponsor or person
Institute
Department of Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
no
Other related organizations
Co-sponsor
Nippon Koukan Hospital
Kitasato University Kitasato Institute Hospital
Shinjyuku Sleep Medical Clinic
Kichijyoji Sleep Medical Clinic
RESM Sleep Respiratory Medicalcareclinic
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 02 | 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
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
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 02 | Day |
Last modified on
| 2017 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029836
