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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041797
Receipt No. 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 2020/09/15

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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
Email 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
Email hidenaka@tokyo-med.ac.jp

Sponsor
Institute Neuropsychiatric Research Institute
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 15 Day
Last follow-up date
2021 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
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047624

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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