UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010831 |
|---|---|
| Receipt number | R000012684 |
| Scientific Title | Effects of hypnotic on continuous positive airway pressure adherence |
| Date of disclosure of the study information | 2013/05/31 |
| Last modified on | 2016/05/05 12:02:43 |
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Basic information
Public title
Effects of hypnotic on continuous positive airway pressure adherence
Acronym
Hypnotice and CPAP adherence
Scientific Title
Effects of hypnotic on continuous positive airway pressure adherence
Scientific Title:Acronym
Hypnotice and CPAP adherence
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether hypnotic (Eszopiclone) improves CPAP adherence in sleep apnea syndrome with initial CPAP
intolerance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
average duration of CPAP usage for 4 weeks after the start of hypnotic
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Administration of Eszopiclone
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
1) severe sleep apnea syndrome (AHI->20)
2) being treated by CPAP
3) CPAP intolerance
Key exclusion criteria
1) patients who are prohibited to take Eszpiclone
2) patients without informed consent
3) patients with severe hypoxemia at night
4) patients on psychiatric medication
5) patients with untreated nasal diseases such as deviation of nasal septum
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Ogawa |
Organization
Keio University School of Medicine
Division name
Otolaryngology- head and neck surgery
Zip code
Address
35 Shinanomachi, Shinjuku
TEL
0353633827
oishin@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Oishi |
Organization
Keio University School of Medicine
Division name
Department of otolaryngology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 1608582
TEL
0353633827
Homepage URL
http://www.ccr.med.keio.ac.jp/rinri/index.html
oishin@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Otolaryngology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 31 | 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 | 29 | Day |
Last modified on
| 2016 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012684
