Sleep Clinical Trial
Official title:
A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea
Verified date | October 2018 |
Source | John Hunter Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of
haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor
daytime function and increased risk of motor vehicle incidents.
One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep
apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few
seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart
attack and stroke, which are the leading causes of death in dialysis patients.
In this project, the investigators will examine how a change of dialysis treatment might
improve sleep. This project will first identify patients at risk of sleep disturbance using
surveys and a subsequent sleep study. The investigators will then test different dialysis
models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a dialysis
model that works better for patients with sleep apnoea.
Status | Completed |
Enrollment | 17 |
Est. completion date | October 18, 2018 |
Est. primary completion date | October 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria - Individuals receiving maintenance haemodialysis under the care of Nephrology Department, John Hunter Hospital & Manning Base Hospital - Have received dialysis for more than 3 months. - Greater than 18 years of age - Able to provide informed consent - Satisfactory written and spoken English language skills - AHI score between 15-29 or above 30 if the participant a. declines sleep apnoea treatment after discussing with their physician, b. would like to be involved in the trial whilst awaiting an appointment in the sleep clinic. Exclusion criteria - Acute dialysis or acutely unwell patients - Home dialysis patients - Unable to participate in the study in the opinion of the participant's primary Nephrologist or due to language barrier or cognitive impairment. - Already on treatment for sleep-disordered breathing - Woman who are pregnant |
Country | Name | City | State |
---|---|---|---|
Australia | John Hunter Hospital | Newcastle | New South Wales |
Australia | John Hunter Hospital | Newcastle |
Lead Sponsor | Collaborator |
---|---|
John Hunter Hospital | Hunter Medical Research Institute, Newcastle University |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Sleep Apnea measured by Apnea-hypopnea index | The Apnea-Hypopnea Index (AHI) score will be used to determine the severity of sleep apnea. The AHI will be obtained via an overnight sleep study. An AHI score of 5-14.9/hr is classified mild sleep apnea, 15-29.9/hr is moderate and above 30/hr is severe sleep apnea. | 18 months | |
Secondary | Patient-reported sleep quality measured by PSQI | The subjective sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). The PSQI is an effective tool to measure the quality and patterns of sleep, and to differentiate "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month period. A global sum of 5 or greater indicates "poor" sleep. | 18 months | |
Secondary | Patient-reported daytime sleepiness measured by ESS | The subjective sleep quality will also be measured by Epworth Sleepiness Scale (ESS). ESS is an eight-item survey that assesses an individual's level of daytime sleepiness. A score of greater than ten (out of 24) is considered to be indicative of abnormal sleepiness, and 16 or more as severe sleepiness | 18 months | |
Secondary | Overall quality of life measured by KDQoL-36 | Overall quality of life will be measured by Kidney Disease Quality of Life Instrument (KDQOL-36). This tool examines 20 variables which include renal specific measurements. The domains examined include physical and social functioning, physical and emotional role limitations, physical pain, mental health, vitality, general health perceptions plus the burden of kidney disease, and symptoms/problems commonly associated with kidney disease. The score of KDQoL-36 ranges from 0-100, and higher score indicates higher quality of life reported by patients. | 18 months | |
Secondary | The different concentration of inflammatory biomarkers (CRP, ß2M, TNF-a, IL-6 and IL-8) during HDF period vs HD period, and the correlation to AHI, and overall sleep quality and quality of life. | Blood samples will be collected from eligible participants in stage 2, and analysed for inflammatory biomarkers concentration using Elisa kit. | 18 months |
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