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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038489
Receipt No. R000043861
Scientific Title Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment
Date of disclosure of the study information 2020/12/29
Last modified on 2020/12/29

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Basic information
Public title Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment
Acronym SAS and continuous glucose monitoring
Scientific Title Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment
Scientific Title:Acronym SAS and continuous glucose monitoring
Region
Japan

Condition
Condition sleep apnea syndrome
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between sleep apnea syndrome(SAS)and continuous glucose monitoring(CGM)and the effect of Positive Airway Pressure treatment(CPAP) on CGM.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of CPAP treatment on continuous glucose monitoring 1 week before and after the start of treatment.
Key secondary outcomes The relationship between sleep apnea syndrome and continuous glucose monitoring.

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 1 week 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

Not applicable
Gender Male and Female
Key inclusion criteria 1)SAS patients with AHI 15 or greater.
2)patients with informed concent.
Key exclusion criteria 1) Patients with a history of diabetes treatment.
2) CPAP usage time less than 4 hours
3) Patients whose measured blood glucose level and CGM difference is 20mg / dl or more
Target sample size 40

Research contact person
Name of lead principal investigator
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
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 三重スリープクリニック(三重県)

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 29 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 Completed
Date of protocol fixation
2017 Year 11 Month 07 Day
Date of IRB
2017 Year 11 Month 21 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2020 Year 05 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
2019 Year 11 Month 04 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=R000043861

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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