Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 12/31/2014 |
| Първо изпратено: | 12/09/2013 |
| Очаквано записване подадено: | 12/17/2013 |
| Първо публикувано: | 12/18/2013 |
| Изпратена последна актуализация: | 01/05/2015 |
| Последна актуализация публикувана: | 01/06/2015 |
| Действителна начална дата на проучването: | 11/30/2013 |
| Приблизителна дата на първично завършване: | 04/30/2014 |
| Очаквана дата на завършване на проучването: | 04/30/2014 |
Състояние или заболяване
Интервенция / лечение
Drug: Carbocysteine
Device: Continuous Positive Airway Pressure
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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 . |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
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]
Вторични изходни мерки
1. Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment . [after 6 weeks treatment]
Други изходни мерки
1. Change of vascular function after oral intake of Antioxidant Carbocysteine [after 6 weeks after oral intake of Carbocysteine treatment]
