Effect of CPAP on Biomarkers in Patients With OSA (CPAP)
Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
연구 개요
상태
정황
상세 설명
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms.However, it is a costly treatment option and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.
This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Surendra K Sharma, MD, Ph.D
- 전화번호: 91-11-26594415
- 이메일: sksharma@aiims.ac.in
연구 장소
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Delhi
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New Delhi, Delhi, 인도, 110029
- 모병
- All India Institute of Medical Sciences
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부수사관:
- Manish Soneja, MD
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연락하다:
- Surendra K Sharma, MD, Ph.D
- 전화번호: 91-11-26594415
- 이메일: sksharma@aiims.ac.in
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수석 연구원:
- Surender K Sharma, MD, Ph.D
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부수사관:
- M Irshad, MD
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부수사관:
- Vishubhatla Sreenivas, Ph.D
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부수사관:
- Ramakrishnan Lakshmy, Ph.D
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부수사관:
- Atin Kumar, MD
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부수사관:
- Priya Jagia, MD
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부수사관:
- Deepak Damodaran, M.B.B.S.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
The 1st part of the study will include
- males and females, aged 30-65 years,
- with AHI >5 and excessive daytime sleepiness
- naïve to CPAP treatment.
- Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension
Exclusion Criteria:
- Hypothyroidism
- Chronic renal failure
- Chronic liver disease
- Chronic lung disease
- Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
- Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
- Immune deficiency conditions
- Pregnancy
- Active menstruation at time of sampling
- Macroalbuminuria (aACR>300mg/g),
- Patients of coronary artery disease and left ventricular dysfunction
- Not on treatment for hypertension, diabetes mellitus or dyslipidemia
- Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 1
Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit 3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
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3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
다른 이름들:
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다른: 2
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
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3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Effect of CPAP therapy on blood pressure
기간: 7 months
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7 months
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Effect of CPAP therapy on insulin resistance
기간: 7months
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7months
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Effect of CPAP therapy on plasma hs-CRP
기간: 7months
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7months
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Effect of CPAP therapy on lipid profile
기간: 7months
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7months
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Effect of CPAP therapy on urinary albumin-creatinine ratio
기간: 7months
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7months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Effect of CPAP on anthropometric parameters
기간: 3 months
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3 months
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Effect of CPAP on visceral fat and other imagings
기간: 3months
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3months
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Effect of CPAP on carotid intima medical thickness
기간: 3months
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3months
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Effect of CPAP on adipokines and oxidative stress markers
기간: 3months
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3months
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Effect of CPAP on inflammatory cytokine levels.
기간: 3months
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3months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Surendra K Sharma, MD,Ph.D, All India Institute of Medical Sciences, New Delhi
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SKS/CPAP-OSAS/2009
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AutoSet Spirit--Wash--Modified-AutoSet Spirit에 대한 임상 시험
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University of Lisbon완전한
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Göteborg UniversityEisai Inc.완전한
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Centre Hospitalier Universitaire de Saint EtienneAssociation Lyonnaise de Logistique Posthospitalière종료됨