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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042541
Receipt No. R000048557
Scientific Title Efficacy of Bilevel-auto CPAP treatment after switching from Auto-CPAP treatment in OSA patients
Date of disclosure of the study information 2021/01/01
Last modified on 2020/12/29

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Basic information
Public title Efficacy of Bilevel-auto CPAP treatment after switching from Auto-CPAP treatment in OSA patients
Acronym Efficacy of Bilevel-auto CPAP treatment
Scientific Title Efficacy of Bilevel-auto CPAP treatment after switching from Auto-CPAP treatment in OSA patients
Scientific Title:Acronym Efficacy of Bilevel-auto CPAP treatment
Region
Japan

Condition
Condition Sleep apnea syndrome
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the usefulness of Bilevel auto CPAP treatment for obstructive sleep apnea
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the average usage time, average usage rate, and AHI for 1 months before and after switching from the conventional Auto CPAP to Bilevel auto CPAP mode.
Key secondary outcomes To compare the average CPAP pressure, average leak time and %, apnea/hypopnea events, CSR% for 1 months before and after switching from the conventional Auto CPAP to Bilevel auto CPAP mode. To examine the characteristics of a group of patients who have been ineffective with conventional Auto CPAP treatment.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 2 months of CPAP treatment
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)OSA patients with AHI 20 or greater at PSG
2)Patients who have been on CPAP treatment for more than 3 months
3) Patient after mask fitting
4) Patients who have received informed consent
Key exclusion criteria 1)Major uncontrolled medical or psychiatric conditions
2)chronic respiratory failure or insufficiency
3)Surgery on the upper airway, nose, sinus, or middle ear within 90 days of participation
4)Cases of severe rhinitis or sinusitis complications
5)The presence of any untreated and diagnosable non-OSA sleep disorder (e.g., restless legs syndrome, insomnia, PLMD)
6)Current shift workers
7)Known history of alcohol or drug abuse within the past3 years
8)Nocturia, cases of BPH and other urological diseases
Target sample size 200

Research contact person
Name of lead principal investigator
1st name KIMIMASA
Middle name
Last name SAITO
Organization Mie Sleep Clinic
Division name Depertment of Respiratory
Zip code 5190502
Address 446 sogo obata Ise,Mie
TEL +81-596-29-1159
Email k1saito@carrot.ocn.ne.jp

Public contact
Name of contact person
1st name KIMIMASA
Middle name
Last name SAITO
Organization Medical corporation MSC
Division name Mie Sleep Clinic
Zip code 5190502
Address 446 sogo obata Ise,Mie
TEL +81-596-29-1159
Homepage URL
Email k1saito@carrot.ocn.ne.jp

Sponsor
Institute Medical corporation MSC
Mie Sleep Clinic
Institute
Department

Funding Source
Organization Medical corporation MSC
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 Medical corporation MSC
Address 446 sogo obata Ise,MIe
Tel +81-596-29-1159
Email k1saito@carrot.ocn.ne.jp

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 医療法人MSC(三重県) 三重スリープクリニック(伊勢市)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 01 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 11 Month 05 Day
Date of IRB
2020 Year 11 Month 18 Day
Anticipated trial start date
2020 Year 12 Month 01 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

Management information
Registered date
2020 Year 11 Month 24 Day
Last modified on
2020 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048557

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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