UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041797 |
|---|---|
| Receipt number | R000047624 |
| Scientific Title | Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2022/09/20 09:13:34 |
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Basic information
Public title
Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan
Acronym
The impact of severe obesity on sleep apnea
Scientific Title
Study on the characteristics in severe obese patients with suspected sleep-disordered breathing in Japan
Scientific Title:Acronym
Study on the phenotype of sleep-disordered breathing in severe obese patients in Japan
Region
| Japan |
Condition
Condition
Sleep-disordered breathing
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the clinical differences between patients with and without diurnal and/or nocturnal hypercapnia in severe obese patients with suspected sleep-disordered breathing.
Basic objectives2
Others
Basic objectives -Others
To compare the early adherence and the symptoms improvement in patients who initiated continuous positive pressure (CPAP) therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
symptoms, physical findings, lung function, biochemistry, cardiac echo (if possible), polysomonographic findings, and the prevalence of obesity hypoventilation, sleep hypoventilation and typical obstructive sleep apnea.
Key secondary outcomes
CPAP level, adherence, the change of sleepness(ESS), and drop-out rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Severe obesity patients (Body mass index(BMI) >= 35kg/m2)
2. Patients with suspected sleep apnea
Key exclusion criteria
Patients with
1. uncontrollable congestive heart failure
2. psychiatric disease under treatment
3. respiratory failure on oxygen
4. undesirable patients judged by doctors
and
5. patients without informed consents
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Nakayama |
Organization
Neuropsychiatric Research Institute
Division name
Japan Somnology Center
Zip code
1510053
Address
Yoyogi 5-10-10, Shibuya-ku, Tokyo, JAPAN
TEL
0334603033
hidenaka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Nakayama |
Organization
Neuropsychiatric Research Institute
Division name
Japan Somnology Center
Zip code
1510053
Address
Yoyogi 5-10-10, Shibuya-ku, Tokyo, JAPAN
TEL
0334603033
Homepage URL
hidenaka@tokyo-med.ac.jp
Sponsor or person
Institute
Neuropsychiatric Research Institute
Institute
Department
Personal name
Funding Source
Organization
TEIJIN PHARMA LIMITED
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
Neuropsychiatric Research Institute
Address
Bentencho 91, Shinjuku-ku, Tokyo, JAPAN
Tel
0302609171
nakayama@somnology.com
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
| 2020 | Year | 09 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047624
