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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018713
Receipt No. R000021310
Scientific Title Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment
Date of disclosure of the study information 2015/08/20
Last modified on 2018/04/13

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Basic information
Public title Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment
Acronym Pathophysical analysis study of sleep-disordered breathing(Pathophysiological SDB study)
Scientific Title Pathophysiological analysis of sleep-disordered breathing toward building the individualized treatment
Scientific Title:Acronym Pathophysical analysis study of sleep-disordered breathing(Pathophysiological SDB study)
Region
Japan

Condition
Condition Sleep-disordered breathing
Classification by specialty
Pneumology Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the feasibility and effectiveness of the treatment according to the pathophysiological evaluation of upper airway collapsibility, stability of breathing and arousability.
Basic objectives2 Others
Basic objectives -Others Human study to analyze the pathophysiology of SDB
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ventilatory response (ventilation, respiratory rate, arousal timing) to compute upper airway collapsibility,
unstable control of breathing and arousability on the experimental day.
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 Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Repeated dial-down and dial-up of continuous positive airway pressure (CPAP) to see respiratory response to the intervention of several different level.
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 Obstructive sleep apnea patients who are during treatment
Key exclusion criteria 1. Unstable comorbidity
2. Respiratory failure
3. Renal failure on hemodialysis
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Nakayama
Organization Tokyo Medical University
Division name Department of Respiratory Medicine
Zip code
Address 6-7-1 Nishi-shinjuku, Shinjuku-ku, TOKYO
TEL 03-3342-6111
Email hidenaka@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Nakayama
Organization Tokyo Medical University
Division name Department of Respiratory Medicine
Zip code
Address 6-7-1 Nishi-shinjuku, Shinjuku-ku, TOKYO
TEL 03-3342-6111
Homepage URL
Email hidenaka@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 08 Month 20 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
2014 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 28 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Twenty eight cases were enrolled until March, 2018.

Management information
Registered date
2015 Year 08 Month 18 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021310

Research Plan
Registered date File name
2017/08/19 病態SDB研究計画書ver. 4.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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