DARIdorexant efficacy on the COGnitive performance in patients with chronic insomnia disorder. DARI-COG Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;
研究概览
简要总结
Confirm in a real-world study the effectiveness of daridorexant 50 mg/day in patients with chronic insomnia disorder, who will start the drug as common clinical practice and according to indication to monitor subjective sleep and daytime symptoms at 3 month and 6 month follow-up visit
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥18 years old and < 65 years old with a diagnosis of chronic insomnia disorder according to the ICSD-3;
- •Starting daridorexant 50 mg daily according to the regulatory approved indication;
- •Patients who are able and willing to give written informed consent, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply with the study requirements.
排除标准
- •Concomitant sleep disorders
- •Major psychiatric disorders
- •Patients contraindicated for daridorexant use (according to SmPC)
- •Dose adjustment of daridorexant or prescription to 25 mg/day
- •Pregnancy or planned pregnancy
- •History of suicide ideations and/or attempts
- •History of epilepsy
- •Previous cerebrovascular diseases
- •Heavy smoking
- •Use of drugs affecting cognition
- •Body Mass Index >35
结局指标
主要结局
1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;
1. Change in insomnia severity index (ISI) total score at 3- and 6-month follow-up visits; 2. Change in subjective total sleep time (sTST) measured by sleep diary in the 7 days before the visit planned at 3- and 6-month follow-up;
次要结局
- Change in cogn perf (attention and memory) measured by neuropsychological tests at the 3and 6monthFUvisits;Change in PSQI total and sub-items scores at 3and 6monthFUvisits;Change in ESS scores at 3and 6monthFUvisits;Change in MEQ scores at 3and 6monthFUvisits;Change in Beck Depression Inventory-II total score at 3and 6monthFUvisits;Change in the mental and physical component of the SF-12 at 3and 6monthFUvisits.
研究者
Claudio Liguori
Scientific
Universita' Degli Studi Di Roma Tor Vergata