Sleep Disturbance in Patients With End-Stage Renal Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD
研究概览
简要总结
Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients.
Project Aims
The aims of this project were three-fold:
- To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD
- To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort
- To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD
详细描述
Patients will not selected based on presence/absence of sleep disturbance. Patients will be prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality is planned.
Patients will be selected for inclusion if they were >16 years old, competent to independently undertake the informed consent process and are currently on RRT or planned to start RRT in the next three months. The following exclusion criteria will be applied: dementia, active malignancy, major psychiatric disorder, home oxygen therapy, CPAP therapy, and regular benzodiazepine use.
Baseline Evaluation
Baseline evaluation includes the following:
- Demographics and clinical parameters including medications and caffeine intake
- Dialysis prescription and adequacy (weekly standardised Kt/V)
- Laboratory data (haemoglobin, iron, phosphate, PTH)
- Subjective sleep quality as measured by Berlin Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and International Restless Leg Syndrome Questionnaire
- Quality of Life as assessed by the 36 Item Short Form Survey (SF-36), Beck Depression Index and Centre for Epidemiologic Studies-Depression Scale
- Cognitive assessment as measured by Trail Making Tests 1 & 2, Category Fluency, Controlled Oral Word Association Test and Hopkins Verbal Learning Test
- Unattended home polysomnography set-up up by investigator who was blinded to the results of the above assessments
- Wrist actigraphy for 3-5 continuous days (Philips Respironics Actiwatch 2 System)
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>16 years old,
- •competent to independently undertake the informed consent process
- •currently on RRT or planned to start RRT in the next three months.
排除标准
- •Patients consuming Benzodiazepine medication
- •Patients requiring nasal CPAP for sleep apnoea
- •Patients requiring supplemental oxygen
- •Patients with dementia, malignancy, or psychiatric disorder
结局指标
主要结局
The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD
时间窗: 18 months
from the total sample population of 60
次要结局
- Change in Subjective Sleep Quality following change of RRT modality(6 months)
- Change in objective sleep quality following change of RRT modality(6 months)
研究者
Claire Kennedy
Clinical Research Fellow
Beaumont Hospital