Effect of CCK antagonists in Obstructive Sleep Apnea (OSA) syndrome.A randomized, double-blind, cross-over study

Rottapharm S.p.A.0 个研究点开始时间: 2013年11月22日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•1.Signed and dated informed consent obtained before undergoing any trial-specific procedure
•2.Male patients aged between 30 and 60 years.
•3.Patients with medically uncomplicated OSA (diagnosed according to American Academy of Sleep Medicine guideline).
•4.Patients naïve to any form of treatment [Behavioral, Oral Appliances, Surgical, Adjunctive, continuous (CPAP), bi-level (BPAP), or autotitrating (APAP) Positive Airway Pressure].
•5.Patients with Apnea-Hypopnea Index (AHI) = 30.
•6.Patients able to communicate, participate and comply with the requirements of the entire study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Patients with arterial oxygen saturation < 75% for > 5% of total sleep time, based on screening ambulatory monitoring.
•2.Patients with Body Mass Index (BMI) =32.
•3.History of rotating or permanent night shift work within 6 months.
•4.Significant cardiovascular (except controlled arterial hypertension), endocrine, hematologic, metabolic, neurologic (including epilepsy), psychiatric, pulmonary, renal disorder, or sleep disorder other than obstructive sleep apnea (OSA), documented by physical or laboratory examination or by medical history.
•5.Patients with any abnormality in ECG, vital signs or laboratory determination judged clinically significant by the investigator.
•6.Patients with a history of drug, alcohol or other abuse substance or other factors limiting their ability to co-operate during the study.
•7.Patients with known hypersensitivity to any of the test materials
•8.Patients who were already taking other investigational drugs/treatments, or who had taken part in a clinical study within the previous 3 months.

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