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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010713
Receipt No. R000012096
Scientific Title The assessment of effectiveness and safety of Nozovent Anti-Snoring Spray for snore patients
Date of disclosure of the study information 2013/05/14
Last modified on 2013/05/14

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Basic information
Public title The assessment of effectiveness and safety of Nozovent Anti-Snoring Spray for snore patients
Acronym The assessment of effectiveness and safety of Nozovent Anti-Snoring Spray for snore patients
Scientific Title The assessment of effectiveness and safety of Nozovent Anti-Snoring Spray for snore patients
Scientific Title:Acronym The assessment of effectiveness and safety of Nozovent Anti-Snoring Spray for snore patients
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of a Nozovent Anti-Snoring Spray in the treatment of snoring
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Snoring sounds (intensity, fundamental frequency, frequency spectrums)
latency
total snore time

Key secondary outcomes patients' subjective evaluation
respiratory parameters
sleep quality

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Before sleep, Anti-Snoring Spray should be used in the next procedure.
1)The bottle should be shaken carefully before being used.
2)Tip head backwards and spray two times against the upper side of the pharynx.
3)Hold breath for 10 seconds.
4)Tip head backwards and spray two times against the upper side of the pharynx again.
5)Hold breath for 10 seconds.
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 simple snorer or OSAS patients 20 years old or older
Key exclusion criteria The patients who has an allergy against cooking oil, those with the severe complication of respiratory or heart disease, those who are pregnant or lactating, those who are receiving another clinical trail, and those who had received other clinical trail within 4 month before are excluded.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamashita
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Otolaryngology
Zip code
Address 1-1-1 Minamikogushi, Ube, JAPAN
TEL 0836-22-2281
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Otolaryngology
Zip code
Address
TEL 0836-22-2281
Homepage URL
Email

Sponsor
Institute Department of Otolaryngology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nitto Pharmaceutical Industries,Ltd
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 14 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
2012 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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

Management information
Registered date
2013 Year 05 Month 14 Day
Last modified on
2013 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012096

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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