The Effect of Haemodialysis in Sleep Apnoea

NCT02939586 | Completed DMC

• 1 other identifier: JohnHunterH
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Apnoea; Renal Failure; End Stage Kidney Disease; Sleep Disturbance; Sleep Disorders; Sleep

Keywords

Sleep, Sleep apnoea, Haemodialysis, Haemodiafiltration, end stage kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-reported sleep quality measured by PSQI

  18 months

• Patient-reported daytime sleepiness measured by ESS

  18 months

• Overall quality of life measured by KDQoL-36

  18 months

• The different concentration of inflammatory biomarkers (CRP, β2M, TNF-α, IL-6 and IL-8) during HDF period vs HD period, and the correlation to AHI, and overall sleep quality and quality of life.

  18 months

Study Arms (2)

Haemodialysis

ACTIVE COMPARATOR

regular convectional haemodialysis 3times/weekly

Procedure: Haemodiafiltration post-dilution model

Haemodiafiltration

ACTIVE COMPARATOR

post-dilution haemodiafiltration

Procedure: Haemodialysis

Interventions

Haemodiafiltration post-dilution model PROCEDURE

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.

Haemodialysis

Haemodialysis PROCEDURE

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.

Haemodiafiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• John Hunter Hospital: lead
• Newcastle University: collaborator
• Hunter Medical Research Institute: collaborator

Study Sites (2)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

Location

John Hunter Hospital

Newcastle, Australia

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Renal Insufficiency; Kidney Failure, Chronic; Parasomnias; Sleep Wake Disorders

Interventions

Dialysis

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Vanessa McDonald, PhD

  Academic Clinician/University of Newcastle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Consultant

Model Details: eligible participants from stage 1 screening will be invited to participate in stage 2 RCT. participants will be randomly assigned to either HD or HDF for 2 months, 1 month wash-our period and cross-over to the other treatment for another 2 months. The total trial period will be 5 months.

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 20, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 18, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)