Feasibility of Improvement for Elderly Sleep Disturbance Through Home Care Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months
研究概览
简要总结
Humans spend a third of their time on sleep. Therefore, maintaining a deep, stable and consistent sleep is very important for a good quality of life. Aging is often related to a decrease in the ability to fall asleep and maintain sleep. Getting older, various factors can worsen the normal sleep process, which is essential for restoring function and body function. Aging-related diseases, life changes, or own aging can disrupt the normal sleep cycle and seriously affect healthy aging. For example, the circadian rhythm and sleep consolidation will be broken with normal aging. These changes may lead to aging, or become part of the risk factors for diseases such as Alzheimer's disease. How to avoid disability and dementia by improving the quality of sleep to make the elderly healthy and aging, will bring huge effects to the economy, society, and health care.
From this plan, investigators will participate in an integrated plan (main plan)-" Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging". In the main plan, 500 subjects will be enrolled. All subjects consent to provide medical record and will be tested for sarcopenia, including body composition, 4-meter walk, handgrip strength. The subjects screened sleep-affected subjects. It is estimated that 250 people will be invited for home sleep testing, such as continuous positive pressure breathing aid (CPAP) for sleep apnea (OSA) (approximately 120 subjects). For non-OSA and non-periodic limb movement disorder (PLMS) sleep problems, take a phototherapy program (about 60 subjects). The following goals are expected to be achieved:
- Link to the main project to explore the correlation between common sleep disorders in the elderly and blood pressure, cognition, sarcopenia, metabolomics or intestinal microbiome
- To verify the prognosis of sleep apnea and sleep disorders after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are willing to sign the written subject consent
- •Participants who participated in the integrated project (main project) - "Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging"
- •The results of the sleep questionnaire meet one of the following:
- •Pittsburgh Sleep Quality Scale (PSQI) > 5 points
- •The Self-Sleep Assessment Questionnaire (STOP-BANG) is at high risk for sleep apnea (OSA)
排除标准
- •Patients with severe cataracts who have not received treatment, patients with color blindness and chronic skin diseases (including psoriasis, eczema), or those who are considered by the host to be unable to receive light therapy.
- •Those who are unsuitable after evaluation by a physician.
结局指标
主要结局
Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months
时间窗: 3 months
Subjective sleep quality will be assessed by the PSQI questionnaire. The measure consists of 19 individual items, creating 7 components that produce one global score. Each component is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
次要结局
- Change from baseline total sleep time at 3 months(3 months)
- Change from baseline sleep onset latency at 3 months(3 months)
- Change from baseline appendicular skeletal muscle mass at 3 months(3 months)
- Change from baseline wake after sleep onset (WASO) at 3 months(3 months)
- Change from baseline sleep efficiency at 3 months(3 months)
- Change from baseline handgrip strength at 3 months(3 months)
- Change from baseline gait speed at 3 months(3 months)