UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048557