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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02939586
Registration number
NCT02939586
Ethics application status
Date submitted
17/10/2016
Date registered
20/10/2016
Date last updated
22/10/2018
Titles & IDs
Public title
The Effect of Haemodialysis in Sleep Apnoea
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Scientific title
A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea
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Secondary ID [1]
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JohnHunterH
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea
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Renal Failure
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End Stage Kidney Disease
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Sleep Disturbance
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Sleep Disorders
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Sleep
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Haemodiafiltration post-dilution model
Treatment: Surgery - Haemodialysis
Active Comparator: Haemodialysis - regular convectional haemodialysis 3times/weekly
Active Comparator: Haemodiafiltration - post-dilution haemodiafiltration
Treatment: Surgery: Haemodiafiltration post-dilution model
Participants will be randomly assigned into either HD or HDF group. The participants will received the assigned treatment for 2 months, 1 month wash-out (HD) and cross-over to the other dialysis model- eg. HDF (2months) and switch to HD for 2 months, with 1 month washout period (using standard HD). Haemodialysis post-dilution model will be delivered using fresenius 5008 machine. Prescription for HDF post-dilution will be comparable to HD.
Treatment: Surgery: Haemodialysis
Participants will be randomly assigned into either HD or HDF group. The participants will received the assigned treatment for 2 months and cross-over to the other dialysis model- eg. HD (2months) and switch to HDF for 2 months, with 1 month washout period (using standard HD). Haemodialysis treatment will be delivered using fresenius 5008 machine. treatment time/parameters may vary depends on individual prescription.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Severity of Sleep Apnea measured by Apnea-hypopnea index
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Assessment method [1]
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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.
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Timepoint [1]
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18 months
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Secondary outcome [1]
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Patient-reported sleep quality measured by PSQI
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Assessment method [1]
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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.
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Timepoint [1]
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18 months
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Secondary outcome [2]
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Patient-reported daytime sleepiness measured by ESS
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Assessment method [2]
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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
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Overall quality of life measured by KDQoL-36
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Assessment method [3]
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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.
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Timepoint [3]
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18 months
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Secondary outcome [4]
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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.
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Assessment method [4]
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Blood samples will be collected from eligible participants in stage 2, and analysed for inflammatory biomarkers concentration using Elisa kit.
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Timepoint [4]
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18 months
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/10/2018
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Sample size
Target
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Accrual to date
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Final
17
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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John Hunter Hospital - Newcastle
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Recruitment postcode(s) [1]
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2305 - Newcastle
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Recruitment postcode(s) [2]
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- Newcastle
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Funding & Sponsors
Primary sponsor type
Other
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Name
John Hunter Hospital
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Newcastle University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Hunter Medical Research Institute
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02939586
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Vanessa McDonald, PhD
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Address
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Academic Clinician/University of Newcastle
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02939586
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