Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
2014年6月16日 更新者：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.
調査の概要
状態
完了
条件
詳細な説明
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.
研究の種類
観察的
入学 (実際)
66
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Gwynedd
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Bangor、Gwynedd、イギリス、LL57 2PW
- Betsi Cadwaladr University Health Board
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Residual volume
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：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)
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
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)
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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)
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Marker of inflammation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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Insulin
時間枠：Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Waist circumference
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：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
時間枠：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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
|
Within four weeks of recruitment prior to CPAP treatment
|
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Mean RR interval
時間枠：Within four weeks of recruitment prior to CPAP treatment
|
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
時間枠：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
時間枠：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 (%)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Within four weeks of recruitment prior to CPAP treatment.
|
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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Christopher MN Earing, MSc、School of Sport, Health and Exercise Sciences, Bangor University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年11月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2011年11月24日
QC基準を満たした最初の提出物
2011年11月24日
最初の投稿 (見積もり)
2011年11月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年6月17日
QC基準を満たした最後の更新が送信されました
2014年6月16日
最終確認日
2014年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。