UMIN-CTR Clinical Trial

Basic information
Public title	The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Acronym	The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Scientific Title	The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Scientific Title:Acronym	The effects of nasal obstruction on sustained exercise and high intensity intermittent exercise : Analysis of the treatment indications
Region	Japan

Condition
Condition	nasal obstruction
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this study are as follows: 1) to evaluate the effect of nasal obstruction on sustained exercise and high intensity intermittent exercise. 2) to evaluate of nasal obstruction involved in exercise performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effects of nasal obstruction on various exercises
Key secondary outcomes	Determining the treatment indication level for nasal obstruction

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Normal group / Nasal obstruction group
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	People who habitually exercise moderately
Key exclusion criteria	1) History of hypersensitivity to Naphazoline Nitrate 2) Taking MAO inhibitor 3) History of coronary artery disease, hypertension, hyperthyroidism and diabetes mellitus 4) History of insomnia, dizziness, etc., and due to sympathomimetic drug 5) Pregnant women or women suspected of being pregnant
Target sample size	60

Research contact person
Name of lead principal investigator	1st name yoshimitsu Middle name Last name saito
Organization	St. Marianna University School of Medicine
Division name	otorhinolaryngology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL	044-977-8111
Email	y2saitou@marianna-u.ac.jp

Public contact
Name of contact person	1st name yoshimitsu Middle name Last name saito
Organization	St. Marianna University School of Medicine
Division name	otorhinolaryngology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL	044-977-8111
Homepage URL
Email	y2saitou@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel	0449778111
Email	y2saitou@marianna-u.ac.jp

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	2021 Year 03 Month 19 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 18 Day
Last modified on	2021 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049832