Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome
キーワード
概要
説明
OSAS patients are required to fill in questionnaire.And Inflammation biomarkers and Oxidative Stress biomarkers and ultrasonic will be tested.Then patients are randomly allocated to one of two groups. One group is treated with oral intake of Antioxidant Carbocysteine 500mg tid. The second group is treated with CPAP. After 6 weeks treatment, all patients will take the overnight polysomnogram test again, and take questionnaire, blood , ultrasonic test.
日付
| 最終確認済み: | 12/31/2014 |
| 最初に提出された: | 12/09/2013 |
| 提出された推定登録数: | 12/17/2013 |
| 最初の投稿: | 12/18/2013 |
| 最終更新が送信されました: | 01/05/2015 |
| 最終更新日: | 01/06/2015 |
| 実際の研究開始日: | 11/30/2013 |
| 一次完了予定日: | 04/30/2014 |
| 研究完了予定日: | 04/30/2014 |
状態または病気
介入/治療
Drug: Carbocysteine
Device: Continuous Positive Airway Pressure
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Carbocysteine Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day) | Drug: Carbocysteine carbocisteine (2×250 mg, three times daily) for 6 weeks. The tablets are provided by Baiyunshan Pharmaceutical, China. patients will interviewed after 3 weeks to check their adherence to the study regimen by collecting and counting the number of remaining tablets, record adverse events, and refill study tablets for the next 3 weeks. |
| Active Comparator: Continuous Positive Airway Pressure Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight. | Device: Continuous Positive Airway Pressure Patients will interviewed after 3 weeks and the end of trial.We will check their compliance to device memory download , record adverse events and pressure . |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Male |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Male in an age range of 18 to 65 years 2. Obstructive Sleep Apnoea with an Apnea Hypopnea Index (AHI) of greater than or equal to 15 confirmed by polysomnography 3. The patient is able to provide consent 4. The patient were not receiving therapy for sleep apnoea,such CPAP or surgery. Exclusion Criteria: 1. Inability to tolerate Carbocysteine or CPAP 2. Treatment with CPAP or surgery prior to or at the time of enrolment 3. presence of active acute or chronic infection 4. Patients with unstable cardiovascular diseases (unstable angina, myocardial infarction, stroke, or transient ischemic attacks), neuromuscular diseases, chronic respiratory diseases, peripheral vascular disease 5. Using of steroidal , nonsteroidal anti-inflammatory, vasodilators ,lipid-lowering drugs,or other medications that lower oxidative stress. 6. Intake of central relevant drugs, sedatives, or other drugs which impair sleep 7. Unwilling to participate in the study 8. Participation in another clinical study in the past 4 weeks 9. Shift worker |
結果
主な結果の測定
1. Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment [after 6 weeks]
2. Daytime sleepiness(EDS) after oral intake of Carbocysteine treatment [after 6 weeks]
3. Change of Oxidative Stress after oral intake of Carbocysteine treatment [after 6 weeks]
二次的な結果の測定
1. Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment . [after 6 weeks treatment]
その他の成果対策
1. Change of vascular function after oral intake of Antioxidant Carbocysteine [after 6 weeks after oral intake of Carbocysteine treatment]
