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临床试验/NCT05240261
NCT05240261尚未招募1 期

Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients

Assiut University0 个研究点目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
60
主要终点
1- change in Blood pressure measurement .

研究概览

简要总结

  1. Asses sleep disorders in CKD patients and those on haemodialysis and related complications ( uncontrolled blood pressure,glomerular filtration rate (GFR) ,proteinuria and psychological disturbance)
  2. Asses effect of hypnotics or sedations for 3 month in improvement those complications after taking treatment .

详细描述

Sleep disorders are prevalent in patients with chronic kidney disease (CKD) in particular those with end stage renal disease (ESRD). It has been reported that 80% of ESRD patients receiving dialysis report sleep complaints, with daytime sleepiness to be the most common reported symptom. The reason for increased rates of sleep related issues and disorders in this population is likely multifactorial.

Although it is commonly accepted that patients with CKD experience poor sleep quality, not much is known about the physiological mechanisms underlying this phenomenon. Patients with CKD often exhibit sympatho-vagal imbalance due to baroreceptor reflex function impairment in which there is hyperactivity of the sympathetic nervous system and decreased vagal tone. In healthy individuals, sleep is accompanied by a decrease in sympathetic activity and an increase in vagal tone that leads to a nocturnal dipping of blood pressure. However, patients who have sleep disorders resulting in hypoxemia and sleep fragmentation have been shown to have increased sympathetic nervous system stimulation and decreased parasympathetic activity, which results in a reduced fall in nocturnal blood pressure.

In patients with ESRD, the identification, diagnosis and treatment of sleep disorders is complicated by the overlapping presentation with CKD and other commonly comorbid conditions. One approach to conceptualizing this relationship is to consider sleep disorders as secondary or end product of multiple concurrent and interactive processes. Such processes include psychological disorders (depression, anxiety), lifestyle factors (coffee/nicotine use, sleep hygiene), treatment-related factors (timing of dialysis, daytime napping, production of cytokines, thermoregulatory changes, dialysis disequilibrium syndrome, disruptions in circadian rhythm, medication side effects) as well as intrinsic, ESRD-specific factors (anemia/obstructive sleep apnea (OSA) and other comorbidities, uremia, overall all health and quality of life, alterations in neurotransmitter production).

A poor sleep profile is associated with increased risk of CKD development. Therefore, sleep duration and quality should be considered when developing strategies to improve sleep and thus prevent CKD.

Poor sleep quality, which is commonly found in pre-dialysis CKD patients, is an independent factor associated with cardiovascular damage in CKD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1.patients are between ages 18 and 60 with chronic kidney disease (CKD)( stage III-V) and ESRD Patients on regular haemodialysis > 6 months.and time of start session of dialysis at 5 pm , thrice weekly .
  • Random urine albumin/creatinine ratio of 30 mcg/day or greater (protein in the urine)
  • Patients have ability to complete a sleep survey and must be able to swallow tablets.
  • Patients with compensated heart and liver disease.
  • Not on antipsychotic drugs.

排除标准

  • Patients with history of psychosis.
  • Patients with decompensated heart or liver disease.
  • Patients with diabetes , autoimmune ,thyroid or neurological disorders.

研究组 & 干预措施

ESRAD on regular haemodialysis

Other

30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month.

干预措施: Quetiapine (Drug)

CKD patients (predialydsis)

Other

30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month.

干预措施: Quetiapine (Drug)

结局指标

主要结局

1- change in Blood pressure measurement .

时间窗: 3 months

follow up blood pressure ( millimeters of mercury (mm/hg)

Pittsburgh Sleep Quality Index score (PSQI S).

时间窗: 3 months

Scale 0-21, higher scores indicate worse sleep quality.

The Quality of Life Scale (QOLS)

时间窗: 3 months

Scores can range from 16 to 112. higher scores indicate better life quality.

次要结局

  • proteinuria(3 months)
  • change in Estimated Glomerular filteration rate.(3 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Abd Ellatif Aly Ismael

specialist of nephrology.

Assiut University

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