UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025514 |
|---|---|
| Receipt number | R000029296 |
| Scientific Title | Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome. |
| Date of disclosure of the study information | 2017/01/05 |
| Last modified on | 2017/01/04 15:16:47 |
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Basic information
Public title
Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Acronym
Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Scientific Title
Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Scientific Title:Acronym
Evaluation of ramelteon for insomnia in patients with obstructive sleep apnea syndrome.
Region
| Japan |
Condition
Condition
Insomnia in patients with obstructive sleep apnea syndrome.
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine safety of ramelteon, which is free of muscle relaxing effect unlike other sleeping drugs, for patients with obstructive sleep apnea syndrome
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Apnea hypopnea index after administration of ramelteon for 3 weeks
Key secondary outcomes
Sleep latency after administration of ramelteon for 3 weeks
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of ramelteon (21 days) -> Polysomnography -> Oral administration of placebo (21 days) -> Polysomnography
Interventions/Control_2
Oral administration of placebo (21 days) -> Polysomnography -> Oral administration of ramelteon (21 days) -> Polysomnography
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient with insomnia who has 3% ODI(Oxygen Desaturation Index) higher than 40/hr
Key exclusion criteria
1) Patient who already takes a sleeping drug
2) Patient who want to take a sleeping drug immediately
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Kumamoto |
Organization
Nara Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
mkuma@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Kumamoto |
Organization
Nara Medical University
Division name
Second Department of Internal Medicine
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
mkuma@naramed-u.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 05 | 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
| 2012 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029296
