UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025380 |
|---|---|
| Receipt number | R000029224 |
| Scientific Title | A single-blind cross-over study examining the effects of heated humidification to nasopharynx on snoring and self-reported sleep quality in healthy adult |
| Date of disclosure of the study information | 2016/12/22 |
| Last modified on | 2019/12/31 15:26:18 |
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Basic information
Public title
A single-blind cross-over study examining the effects of heated humidification to nasopharynx on snoring and self-reported sleep quality in healthy adult
Acronym
The effects of heated humidification to nasopharynx on snoring and sleep
Scientific Title
A single-blind cross-over study examining the effects of heated humidification to nasopharynx on snoring and self-reported sleep quality in healthy adult
Scientific Title:Acronym
The effects of heated humidification to nasopharynx on snoring and sleep
Region
| Japan |
Condition
Condition
Habitual snoring
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether heated humidification to nasopharynx improve snoring and self-reported sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The total duration of snoring and snoring sound intensity
Key secondary outcomes
Self-reported sleep quality using visual analog scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
No Intervention (first night) ->Intervention A (second night)->Intervention B (third night)
Intervention A: Applying a test product while sleeping
Intervention B: Applying a placebo product while sleeping.
Interventions/Control_2
No Intervention (first night) ->Intervention B (second night)->Intervention A (third night)
Intervention A: Applying a test product while sleeping
Intervention B: Applying a placebo product while sleeping.
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
The healthy man who has a habitual snoring
Key exclusion criteria
1) Subjects who had been diagnosed as sleep apnea syndrome, or who are under treatment
2) Subjects who have chronic heart failure, chronic respiratory disease, and renal failure
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoo Yamauchi |
Organization
Nara Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
motoo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigemi Tsuchiya |
Organization
Kao Corporation
Division name
Personal Health Care Research
Zip code
Address
2-1-3, Bunka Sumida-ku, Tokyo
TEL
03-5630-7271
Homepage URL
tsuchiya.shigemi@kao.co.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
奈良県立医科大学附属病院（奈良県）、花王株式会社パーソナルヘルスケア研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 22 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029224
