Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
2014년 6월 16일 업데이트: Bangor University
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.
연구 개요
상태
완전한
정황
상세 설명
Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation.
Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important.
This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.
연구 유형
관찰
등록 (실제)
66
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Gwynedd
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Bangor, Gwynedd, 영국, LL57 2PW
- Betsi Cadwaladr University Health Board
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
샘플링 방법
비확률 샘플
연구 인구
Mild to severe recently diagnosed Obstructive Sleep Apnea patients selected by physician who have not received any treatment for their condition.
Selected from Ysbyty Gwynedd in North Wales.
설명
Inclusion Criteria:
- Body Mass Index ≤39
- Not received any treatment for Obstructive Sleep Apnea.
- Is a non-smoker
- Is not epileptic
- Epworth Sleepiness Scale ≥ 10.
- Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.
Exclusion Criteria:
- Body Mass Index ≥ 39.
- Presence of significant or unstable Renal, Liver or Heart Failure.
- Receiving anti-diabetic treatment.
- Is a smoker.
- Is epileptic
- Presence of significant or unstable psychological morbidities.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
기간: one night within four weeks of study.
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AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
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one night within four weeks of study.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Residual volume
기간: Within four weeks of recruitment prior to CPAP treatment
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Volume of air remaining in lungs after full expiration
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Within four weeks of recruitment prior to CPAP treatment
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Functional residual volume
기간: Within four weeks of recruitment prior to CPAP treatment
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Air present in lungs at the end of passive expiration
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Within four weeks of recruitment prior to CPAP treatment
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Total lung capacity
기간: Within four weeks of recruitment prior to CPAP treatment
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Total volume of lungs
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Within four weeks of recruitment prior to CPAP treatment
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Forced Vital capacity
기간: Within four weeks of recruitment prior to CPAP treatment
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Maximum amount of air which can be expired from the lungs following a full inspiration
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Within four weeks of recruitment prior to CPAP treatment
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Forced expiratory volume in one second (FEV1)
기간: Within four weeks of recruitment prior to CPAP treatment
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Maximum amount of air which can be expired from the lungs in one second.
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Within four weeks of recruitment prior to CPAP treatment
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Airway Resistance
기간: Within four weeks of recruitment prior to CPAP treatment
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Opposition of flow caused by forces of friction.
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Within four weeks of recruitment prior to CPAP treatment
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Plasma 2-arachidonoylglycerol (2-AG)
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Ligand of the G-protein coupled CB1 and CB2 receptors, has been found to be correlated with Oleylethanolamide (OEA) in OSA patients have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Plasma Anandamide (ANA)
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Ligand of the G-protein coupled CB1 and CB2 receptors, found to be correlated with blood pressure in OSA after the adjustment of confounding variables.
Have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma oleoylethanolamine (OEA)
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma Leptin
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma Adiponectin
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma C-reactive Protein
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Marker of inflammation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Insulin
기간: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Neck circumference
기간: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Waist circumference
기간: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Hip circumference
기간: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Weight
기간: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Fat-free mass
기간: Within four weeks of recruitment prior to CPAP treatment
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Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Fat mass
기간: Within four weeks of recruitment prior to CPAP treatment
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Fat components of the human body estimated non-invasively using bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Maximal Inspiratory pressure
기간: Within four weeks of recruitment prior to CPAP treatment
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Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
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Within four weeks of recruitment prior to CPAP treatment
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Rate of inspiratory muscle fatigue
기간: Within four weeks of recruitment prior to CPAP treatment
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The decline in maximal inspiratory pressure following inspiration against a resistance.
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Within four weeks of recruitment prior to CPAP treatment
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Chest RPE
기간: Within four weeks of recruitment prior to CPAP treatment
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Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Dyspnea
기간: Within four weeks of recruitment prior to CPAP treatment
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Rating of breathlessness half way through fatigue protocol and at the end of protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 25% O2/ 6% CO2
기간: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2
기간: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2 / 6% CO2
기간: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
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Within four weeks of recruitment prior to CPAP treatment
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Mean RR interval
기간: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: Average time interval between the heart beats R waves
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Within four weeks of recruitment prior to CPAP treatment
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SDNN
기간: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The standard deviation of all RR intervals
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Within four weeks of recruitment prior to CPAP treatment
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NN50 count
기간: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
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Within four weeks of recruitment prior to CPAP treatment
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NN50 of total HR (%)
기간: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: NN50 count divided by total number of all RR intervals.
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Within four weeks of recruitment prior to CPAP treatment
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HRV triangular index
기간: Within four weeks of recruitment prior to CPAP treatment
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The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
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Within four weeks of recruitment prior to CPAP treatment
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Low frequency domain
기간: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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High frequency domain
기간: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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LF/HF ratio
기간: Within four weeks of recruitment prior to CPAP treatment.
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The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
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Within four weeks of recruitment prior to CPAP treatment.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 11월 1일
기본 완료 (실제)
2014년 6월 1일
연구 완료 (실제)
2014년 6월 1일
연구 등록 날짜
최초 제출
2011년 11월 24일
QC 기준을 충족하는 최초 제출
2011년 11월 24일
처음 게시됨 (추정)
2011년 11월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 6월 16일
마지막으로 확인됨
2014년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (기타 식별자: North West Wales Research Ethics Committee)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .