Multi-center, single-arm, open-label study in patients with Insomnia Disorder to validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)

Idorsia Pharmaceuticals Ltd0 个研究点目标入组 100 人开始时间: 2016年11月30日最近更新: 2018年11月26日

试验速览

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•- Signed informed consent prior to any study-mandated procedure;
•- Male or female aged = 18 years;
•- Body mass index (BMI): 18.5 = BMI (kg/m2) < 32.0;
•- Insomnia disorder according to DSM-5 criteria;
•- Insufficient sleep quantity evaluated according to the self-reported history and data collected in the sleep diary;
•- Insomnia Severity Index score greater than or equal to 15;
•- Complete the IDSIQ™ and the sleep diary questionnaire as required.
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy;
•- Self-reported usual daytime napping = 1 hour per day, and = 3 days per week;
•- Caffeine consumption = 600 mg per day;
•- Shift work within 2 weeks prior to the screening visit, or planned shift work from V1 to V3;
•- Travel = 3 time zones within 1 week prior to the screening visit, or planned travel = 3 time zones from V1 to V3;
•- Known severe renal impairment or know moderate or severe hepatic impairment;
•- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments;
•- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

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