Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly; A Prospective Cohort Study at a Taiwanese Academic Medical Center
试验速览
- 阶段
- 不适用
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Changes from baseline in sleep quality at 12 months
研究概览
简要总结
The aims of this study are to (1) examine the medication use patterns of commonly prescribed hypnotics and the factors that were associated with the long-term and short-term use patterns among the elderly population in Taiwan; (2)investigate the associations of using hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as its pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and humanistic outcomes of using hypnotics and the corresponding contributing factors for the elderly in Taiwan.
详细描述
Aging is associated with the changes in the sleep structure, continuity, and timing while it also affects the elderly's physiological and psychological health statuses. Despite the fact that hypnotics are beneficial for the short-term management of insomnia, it is inconclusive about the risk and benefit ratios of long-term use for the elderly. The objectives of this study are to (1)examine the medication use patterns of prescribed hypnotics and the factors that were associated with the use patterns among the elderly population; (2)investigate the associations of using prescribed hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as their pharmacokinetic and pharmacogenetic characteristics;(3)determine the clinical, economic and humanistic outcomes and corresponding factors of using hypnotics for long-term and short-term use in Taiwanese elderly.
This proposed study is the second part of a larger project that consists of two main phases across four years. The first part will include a retrospective database analysis to examine the medication use patterns for sleep disorders and corresponding outcomes using three data sets. Elderly patients aged 65 or older and who received hypnotics for insomnia will be selected from Taiwan's National Health Insurance Research Database, National Health Interview Survey and China Medical University Hospital (CMUH) in-house databases. Focus will be placed on benzodiazepines (BZD) and BZD-receptor specific non-BZD agents (Z-drugs), but Chinese traditional medication used for insomnia will also be examined.
This study is the second part of the larger project. The investigators will conduct a longitudinal, prospective, observational cohort study over a period of two years. The focus of this study is the use of hypnotic BZD and Z-drugs on elderly insomnia patients. The study cohorts include elderly patients, aged 65 years or older, who have received services in the outpatient departments of China Medical University Hospital, Taichung, Taiwan, and who have been prescribed with a selected BZD or Z-drug for insomnia for at least one week. A control group cohort will also be recruited. Each recruited patient will be monitored and evaluated periodically for at least one year. Economic, clinical, and humanistic outcomes, as well as adherence to the hypnotics will be assessed and monitored. Safety and tolerability will be assessed by occurrence of adverse drug reactions. Pharmacokinetic properties and genotyping patterns will be also be evaluated using snapshot blood sampling after the 6th month of enrollment in the study. The clinical and humanistic outcomes measures will include changes in insomnia status, functional status changes, depression status, as well as over-all well-being using EuroQol 5D. Economic evaluation will compare total insurance and out-of-pocket expenses at baseline and at 12 months follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Estazolam
Exposure to sedative-hypnotic drugs; Patients who have taken estazolam for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Lorazepam
Exposure to sedative-hypnotic drugs; Patients who have taken lorazepam for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Diazepam
Exposure to sedative-hypnotic drugs; Patients who have taken Diazepam for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Alprazolam
Exposure to sedative-hypnotic drugs; Patients who have taken Alprazolam for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Flunitrazepam
Exposure to sedative-hypnotic drugs; Patients who have taken Flunitrazepam for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Zolpidem
Exposure to sedative-hypnotic drugs; Patients who have taken Zolpidem for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
Zopiclone
Exposure to sedative-hypnotic drugs; Patients who have taken Zopiclone for at least one week before the first date of enrollment
干预措施: Exposure to sedative-hypnotic drugs (Drug)
结局指标
主要结局
Changes from baseline in sleep quality at 12 months
时间窗: after 12 months of enrollment
Clinical outcome, measured by a Chinese version of the Pittsburgh Sleep Quality Index
Number of participants with an occurrence of associated ADR
时间窗: after 12 months of enrollment
Safety and tolerably, as measured by patients that experience falls, hip/limb fracture, cognitive impairment, etc. during the 12 months of enrollment
次要结局
- Snapshot measurement of urine drug and metabolite concentrations(after 6 months of enrollment)
- Snapshot measurement of plasma drug and drug metabolite concentrations(after 6 months of enrollment)
- Calculation of drug clearance using snapshot plasma and urine concentrations(after 6 months of enrollment)
- Proportion of patients with CYP3A5 mutations(after 6 months of enrollment)
- Changes from baseline in IADL at 12 months(after 12 months of enrollment)
- Changes from baseline in insomnia at 6 months(After 6 months of enrollment)
- Changes from baseline in sleep quality at 6 months(after 6 months of enrollment)
- Changes from baseline in Barthel Index at 6 months(after 6 months of enrollment)
- Changes from baseline in Barthel Index at 12 months(after 12 months of enrollment)
- Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 12 months(after 12 months of enrollment)
- Changes from baseline in IADL at 6 months(after 6 months of enrollment)
- Changes from baseline in EQ-5D-5L & EQ-5D-VAS at 6 months(after 6 months of enrollment)
- Changes from baseline in insomnia at 12 months(After 12 months of enrollment)
- Changes from baseline in MMAS-8 after 6 months(after 6 months of enrollment)
- Changes from baseline in MMAS-8 after 12 months(after 12 months of enrollment)
- Change from baseline in economic healthcare costs using NHI and out-of-pocket expenses at 12months(At 12 months after enrollment)
研究者
Hsiang-Wen Lin
Associate Professor
China Medical University Hospital