A randomised controlled feasibility study of managing sleep with Zopiclone in participants with acute low back pain and sleep disturbances.

Dr. James McAuley0 个研究点目标入组 22 人开始时间: 2016年1月13日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Low back pain.
•2.Mild to moderate insomnia (Insomnia Severity Index score of between 7-21), of less than 6 weeks duration
•3.Sufficient understanding of written and verbal English language.

•1.Known allergy to sedative drugs
•2. Diagnosed with sleep disorder including sleep apnea, primary hypersomnia, narcolepsy, circadian rhythm disorder, parasomnia or dyssomnia.
•3. Diagnosed with a psychiatric disorder
•4.Diagnosis serious hepatic disorder
•5.Diagnosis severe myasthenia gravis
•6.Diagnosis acute narrow angle glaucoma
•7.Major surgery or blood donation in the past 12 weeks
•8.Pregnancy or expected pregnancy, or breastfeeding
•9. Have a history of substance abuse or substance dependence subjects with alcohol abuse.
•10. Weekly consumption more than 14 units (women) or 21 units (men) of alcohol.
•11.Daily consumption of more than the nicotine-equivalent of 15 cigarettes a day.
•12.Daily consumption of more than 5 caffeine-containing beverages a day/ caffeine consumption of >500 mg/day
•13.Flew >2 time zone in the past month or will have to do so during course of the study
•14. Working night shifts and unable or unwilling to discontinue this work pattern
•15.Presented with any condition that would prevent normal management of low back pain such as cancer.

发起方

Dr. James McAuley