Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Idorsia Pharmaceuticals Ltd.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent prior to any study-mandated procedure;
Male or female aged ≥ 18 years;
Insomnia disorder according to DSM-5 criteria;
Insomnia Severity Index score ≥ 15;
Insufficient sleep quantity as collected subjectively in the sleep diary;
Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
You may not be if
Body mass index below 18.5 or above 40.0 kg/m2;
Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
Mini Mental State Examination (MMSE) score \< 25 in subjects ≥ 50 years;
For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
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.
