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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea
Secondary ID [1] 0 0
JohnHunterH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea 0 0
Renal Failure 0 0
End Stage Kidney Disease 0 0
Sleep Disturbance 0 0
Sleep Disorders 0 0
Sleep 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
18 months

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
- Newcastle

Funding & Sponsors
Primary sponsor type
Other
Name
John Hunter Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Newcastle University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Hunter Medical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02939586
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vanessa McDonald, PhD
Address 0 0
Academic Clinician/University of Newcastle
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications