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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028244
Receipt No. R000032239
Scientific Title Relation between globus pharyngeus and obstructive sleep apnea (OSA) and GERD in patients examined simultaneously by PSG and pH monitor: a cross sectional study
Date of disclosure of the study information 2017/07/18
Last modified on 2017/07/14

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Basic information
Public title Relation between globus pharyngeus and obstructive sleep apnea (OSA) and GERD in patients examined simultaneously by PSG and pH monitor: a cross sectional study
Acronym Relation between globus pharyngeus and obstructive sleep apnea (OSA) and GERD in patients examined simultaneously by PSG and pH monitor: a cross sectional study
Scientific Title Relation between globus pharyngeus and obstructive sleep apnea (OSA) and GERD in patients examined simultaneously by PSG and pH monitor: a cross sectional study
Scientific Title:Acronym Relation between globus pharyngeus and obstructive sleep apnea (OSA) and GERD in patients examined simultaneously by PSG and pH monitor: a cross sectional study
Region
Japan

Condition
Condition Globus pharyngeus
obstructive sleep apnea (OSA)
gastroesophageal reflux disease (GERD)
Classification by specialty
Gastroenterology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the epidemiological frequency of the presence or absence of OSA and the presence or absence of GERD in patients with globus pharyngeus.
Basic objectives2 Others
Basic objectives -Others When the patient with globus pharyngeus had OSA , we verify that symptoms of globus pharyngeus improve by CPAP treatment.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Simultaneously PSG and 24-hour pH monitoring
are performed on patients with globus pharyngeus, and the prevalence rate of OSA andGERD is obtained.
Key secondary outcomes Patients with OSA are treated with CPAP.
Compare the VAS of symptoms of globus pharyngeus before treatment and 3 months after treatment and evaluate improvement.

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 who have non-painful sensation of a lump or foreign body in the throat for more than 3 months.
Key exclusion criteria 1)Patients who can not quit peptic ulcer treatment (PPI, H2 blocker,etc)
2)Patients with any mental disorder or
those who had been instructed to continue all medications that could influence sleep, such as benzodiazepines, were excluded as well.
3)other reasons inadequate for study
participation
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ayako fukui
Organization Nagoya city University
Division name Department of otolaryngology
Zip code
Address Mizuho-cho,Mizuho-ku,Nagoya,467-8601 JAPAN
TEL 052-851-5511
Email bunko-0406@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name ayako fukui
Organization Nagoya city University
Division name Department of otolaryngology
Zip code
Address Mizuho-cho,Mizuho-ku,Nagoya,467-8601 JAPAN
TEL 052-851-5511
Homepage URL
Email bunko-0406@hotmail.co.jp

Sponsor
Institute Department of otolaryngology,Nagoya city University
Institute
Department

Funding Source
Organization Department of otolaryngology,Nagoya city University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 名古屋市立大学大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 18 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 Open public recruiting
Date of protocol fixation
2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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 Exploratory epidemiology study

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2017 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032239

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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