UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010713 |
|---|---|
| Receipt number | 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 11:41:20 |
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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
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
Sponsor or person
Institute
Department of Otolaryngology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012096
