UMIN-CTR Clinical Trial

Basic information
Public title	Effects of CPAP therapy on HDL function in patienst with SAS
Acronym	CPAP and HDL functions
Scientific Title	Effects of CPAP therapy on HDL function in patienst with SAS
Scientific Title:Acronym	CPAP and HDL functions
Region	Japan

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

Objectives
Narrative objectives1	Sleep apnea syndrome (SAS) is characterized by pauses in breathing or periods of shallow breathing during sleep and associated with obesity, male gender, aging. In particular, comorbidity of obesity lead to metabolic syndrome, whereby increasing risk for cardiovascular disease (CVD). The increased risk for CVD is due to increased oxidative stress, inflammation, sympathomimetic tone, and blood pressure, together with insulin resistant. Dyslipidemia is one of major risk factors for CVD and HDL exerts various anti-atherogenic function including macrophage cholesterol efflux capacity, anti-oxidative, anti-inflammatory functions, and improved endothelial function. Effects of CPAP, a mainstay of SAS treatment, on HDL function are unknown. In the present study, we aimed to assess effects of CPAP therapy on HDL functions in patients with SAS.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HDL functions
Key secondary outcomes	lipids and apoproteins

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	12 weeks of CPAP therapy
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	SAS patients with AHI 15 or greater
Key exclusion criteria	1) HbA1c >10% 2) recent cerebrovascular events (6 months) 3) liver dysfunction (AST/ALT greater than 3 fold of upper normal limits) 4) advanced renal inssuficiency including hemodialysis 5) heart failure (NYHA III/IV) 6) cancer or critically ill patients 7) pregnant women 8) serious infection 9) subjects to whom attending doctor judges inappropriate to join the study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Katsunori Middle name Last name Ikewaki
Organization	National Defense Medical College
Division name	Division of Anti-aging and Vascular Medicine
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Saitama
TEL	0429-95-1211
Email	kikewaki@hotmail.com

Public contact
Name of contact person	1st name Katsunori Middle name Last name Ikewaki
Organization	National Defense Medical College
Division name	Division of Anti-aging and Vascular Medicine
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa, Saitama
TEL	0429-95-1211
Homepage URL
Email	kikewaki@hotmail.com

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
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	National defense medical college
Address	3-2 Namiki Tokorozawa Saitama
Tel	0429-95-1211
Email	kikewaki@hotmail.com

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	防衛医科大学校(埼玉)　抗加齢血管内科　耳鼻咽喉科学講座 睡眠総合ケアクリニック代々木(東京)

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 04 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	2016 Year 12 Month 20 Day
Date of IRB	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 04 Month 20 Day
Last follow-up date	2020 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 20 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029159