Armodafinil to reduce the sleepiness related side-effects of Sleep Restriction Therapy being used to treat Insomnia Disorder: An open label pilot study compared to historical matched controls.

Woolcock Institute of Medical Research, Sydney University0 个研究点目标入组 25 人开始时间: 2014年12月11日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1.Males & Females aged 18-70 years.
•2.Able to give informed written consent.
•3.Literacy in English.
•4.Symptoms of Insomnia Disorder as diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder specifically: Difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty. Assessed by telephone screening interview.
•5.Insomnia Severity Index scale scores of 15 or more.
•6.Never previously treated with CBT-I or armodafinil.
•7.At least one month hypnotic free and willing to not take hypnotics for the duration of the trial.

•1.Pregnancy or lactation.
•2.Patients with moderate-severe skin allergies and/or eczema.
•3.Shift workers who rotate to night shift.
•4.Drug addiction or alcoholism.
•5.Severe unstable Psychiatric disorders.
•6.Sleep disorders (other than untreated insomnia) and an apnea-hypopnea index >15 if suspected for sleep apnea.
•7.Severe cognitive impairment that does not allow patients to consent or follow treatment instructions.
•8.Recent time-zone travel (within last 1 month).
•9.Conditions that contraindicate armodafinil or sleep restriction therapy in the opinion of the Principal Investigator (Medical Practitioner).
•9. (a) Liver function tests exceeding the 95% confidence limits of normal which in the opinion of the medical PI contraindicate armodafinil.

发起方

Woolcock Institute of Medical Research, Sydney University