The effect of acute intravenous (iv) morphine administration on Sleep Disordered Breathing (SDB) in patients with moderate Obstructive Sleep Apnoea (OSA): A paired design trial - MIMOSA: Morphine in Moderate Obstructive Sleep Apnoea

Papworth Hospital NHS Foundation Trust - Research and Development Department0 个研究点目标入组 26 人开始时间: 2015年6月30日最近更新: 2020年8月3日

试验速览

暂无简介。

•1.Age = 18 years
•2.Patients with a diagnosis of moderate OSA diagnosed by nocturnal oximetry, rPSG or PSG (defined as AHI or ODI of 15-29 events/hour) established on Continuous Positive Airway Pressure (CPAP)
•3.Patients with confirmed moderate OSA by rPSG 6 nights after withdrawal of CPAP (baseline rPSG)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.Inability to give informed consent or comply with the protocol
•2.History of acute respiratory tract infection or chronic respiratory disease, symptomatic ischemic heart disease
•3.Pregnancy or suspected pregnancy/breast feeding
•4.Current or recent (within last week) use of hypnotic, opioid or sedative drugs
•5.A known allergy to the IMP or NIMP(s)
•6.Patients with an inadequate command of English and requiring an interpreter overnight
•7.Change in weight of > 5% since the baseline rPSG
•8.Vital signs recordings (oxygen saturations, blood pressure, pulse rate) that in clinician's opinion make it unsafe for the patient to participate in the trial
•9.Clinician deems patient unsafe to participate in the trial (e.g. severely sleepy patients who cannot withdraw from CPAP)
•10.CPAP intolerant/poor responder
•11.History of Intravenous (iv) drug abuse
•12.Patient unable to organise transport home following the study visit
•13.Professional driver

发起方

Papworth Hospital NHS Foundation Trust - Research and Development Department