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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026368
Receipt No. 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

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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
Email 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/
Email wakako@df6.so-net.ne.jp

Sponsor
Institute Department of Medicine, Keio University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029836

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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