UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042541 |
|---|---|
| Receipt number | 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 | 2022/05/27 13:57:16 |
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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
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
k1saito@carrot.ocn.ne.jp
Sponsor or person
Institute
Medical corporation MSC
Mie Sleep Clinic
Institute
Department
Personal name
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
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
Terminated
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
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048557
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
