UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028244
Receipt number 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 17:01:17

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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 or person

Institute

Department of otolaryngology,Nagoya city University

Institute

Department

Personal name



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

Value
https://center6.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