NCT02321449已完成不适用
Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change from baseline in quality of sleep questionnaire
研究概览
简要总结
To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
- •Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
- •Patients able to follow the study protocol
- •Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
- •Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
- •Patients who have just been identified to receive treatment with Circadin
- •Patients without previous treatment with Circadin
排除标准
- •Hypersensitivity to any components of Circadin
- •Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
- •Pregnancy and lactation
- •Alcohol or drug addiction
- •Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
- •Intake of psychoactive medicines within the last 30 days before observational study entry
- •Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
- •Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders
结局指标
主要结局
Change from baseline in quality of sleep questionnaire
时间窗: Baseline, 3 weeks
Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.
次要结局
- Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment(3 weeks)
- Change from baseline in attention Questionnaire(Baseline, 3 weeks)
- Change from baseline in memory Questionnaire(Baseline, 3 weeks)
研究者
研究点 (3)
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