Sleep ApnoeaNCT02939586
The Effect of Haemodialysis in Sleep Apnoea
A study testing Haemodiafiltration post-dilution model and Haemodialysis in people with Sleep Apnoea and Renal Failure, run by John Hunter Hospital at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnoea, Renal Failure, End Stage Kidney Disease
- What is being tested?
- Haemodiafiltration post-dilution model and Haemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2016to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
John Hunter Hospital
Newcastle, New South Wales, 2305
John Hunter Hospital
Newcastle
About this study
Official title: A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea
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.
Read the detailed description
Sleep Problem in Dialysis Patients Sleep apnoea is a significant issue in patients with end stage kidney disease. Evidence suggests that up to 80% of dialysis patients have sleep apnoea [1], yet the standard haemodialysis treatment does not improve the symptoms of sleep disturbance in most patients [2].
Sleep disturbance is specifically associated with poor quality of life (QoL) [4]; decreased mental and physical function, and adversely impact survival [5-7]. Recent data also suggest that the low oxygen state resulting from sleep apnoea can exaggerate the deterioration of kidney function and increase risk of high blood pressure, cardiovascular abnormality and overall death rates [8]. Despite the significance of sleep apnoea, it is acknowledged that there is insufficient evidence for clinicians to manage this common symptom burden in the dialysis population [9]; and patients who receive maintenance dialysis today still experience poor QoL and worse survival rates compared with most common cancer sufferers [10].
Knowledge Gap It is believed that the mechanism of sleep apnoea in dialysis patients are related to overactive chemoreceptors, which cause destabilisation of the respiratory drive and periodic breathing during the night [13]. Since the chemoreceptors can be triggered by inflammatory blood toxins, which accumulate in kidney failure [14], it is proposed that better clearance of these molecules can improve symptoms and outcomes of sleep apnoea. These molecules are poorly removed by standard haemodialysis [15] and are thought to cause the symptomatic effects of poor kidney function and inflammation, which are associated with poor sleep quality [16].
Better dialysis treatment may play an important role in the management of sleep apnoea. Previous studies have suggested that sleep apnoea may be improved by nocturnal dialysis; an intensive treatment which patients undergo at home, during sleep, for 8-10 hours every night. It provides better blood purification, compared with standard haemodialysis treatment. However, nocturnal dialysis is a home therapy which is not viable for the majority of haemodialysis patients who require care in a clinical setting. There is clearly a need to explore the effectiveness of dialysis treatment on sleep apnoea using a different dialysis model.
Modern dialysis technology, such as Haemodiafiltration (HDF), allows for better removal of toxic molecules such as beta 2 microglobulin (B2M) and C-Reactive protein (CRP), than standard haemodialysis treatment, and may offer the benefits of nocturnal dialysis to all dialysis patients. No one has examined the effect of HDF on sleep apnoea in haemodialysis patients, and the investigators will answer this question in this study.
Research Aims
- To determine the prevalence of sleep apnoea in the local dialysis population using a validated questionnaire and sleep study. Although sleep apnoea is recognised as common in the dialysis population, there is a need to reproduce this data in the context of local dialysis services to accurately identify affected patients
- To examine the effect of HDF compared conventional haemodialysis on health status and sleep quality in patients with sleep apnoea, using a randomised cross-over trial (RCT)
- To determine if the clearance of middle-sized uraemic toxins improves symptoms of sleep apnoea. The middle-sized molecules to be assessed in this study include C-Reactive protein (CRP), beta 2-microglobulin (β2M), tumour necrosis factor alpha (TNF-α), interleukin 6 (IL-6), and interleukin 8 (IL-8), which are the serum inflammatory markers that are commonly found in patients with obstructive sleep apnoea.
- Conditions
- Sleep Apnoea, Renal Failure, End Stage Kidney Disease, Sleep Disturbance, Sleep Disorders, Sleep
- Being tested
- Haemodiafiltration post-dilution model, Haemodialysis
- Keywords
- Sleep, Sleep apnoea, Haemodialysis, Haemodiafiltration, end stage kidney disease
- Medical subject headings
- Sleep Apnea Syndromes, Renal Insufficiency, Kidney Failure, Chronic, Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemodiafiltration post-dilution modelProcedure or surgery
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.
HaemodialysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Haemodialysis | Active comparator | regular convectional haemodialysis 3times/weekly Receives: Procedure: Haemodiafiltration post-dilution model |
| Haemodiafiltration | Active comparator | post-dilution haemodiafiltration Receives: Procedure: Haemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
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.
Measured: 18 months
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
Measured: 18 months
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.
Measured: 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.
Blood samples will be collected from eligible participants in stage 2, and analysed for inflammatory biomarkers concentration using Elisa kit.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion1 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Hunter Hospital
- Sponsor type
- Other government
- Collaborators
- Newcastle University, Hunter Medical Research Institute
- Responsible party
- Principal investigator, Ginger Chu, John Hunter Hospital
- Investigators
- Vanessa McDonald, PhD, Principal investigator, Academic Clinician/University of Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939586
- Sponsor's protocol ID
- JohnHunterH
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02939586
- Acronym / sponsor ID
- JohnHunterH
- Conditions
- Sleep Apnoea, Renal Failure, End Stage Kidney Disease, Sleep Disturbance, Sleep Disorders, Sleep
- Keywords
- Sleep, Sleep apnoea, Haemodialysis, Haemodiafiltration, end stage kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- John Hunter HospitalOther government
- Collaborators
- Newcastle University, Hunter Medical Research Institute
- Study start
- Oct 2016
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sleep Problem in Dialysis Patients Sleep apnoea is a significant issue in patients with end stage kidney disease. Evidence suggests that up to 80% of dialysis patients have sleep apnoea [1], yet the standard haemodialysis treatment does not improve the symptoms of sleep disturbance in most patients [2].
Sleep disturbance is specifically associated with poor quality of life (QoL) [4]; decreased mental and physical function, and adversely impact survival [5-7]. Recent data also suggest that the low oxygen state resulting from sleep apnoea can exaggerate the deterioration of kidney function and increase risk of high blood pressure, cardiovascular abnormality and overall death rates [8]. Despite the significance of sleep apnoea, it is acknowledged that there is insufficient evidence for clinicians to manage this common symptom burden in the dialysis population [9]; and patients who receive maintenance dialysis today still experience poor QoL and worse survival rates compared with most common cancer sufferers [10].
Knowledge Gap It is believed that the mechanism of sleep apnoea in dialysis patients are related to overactive chemoreceptors, which cause destabilisation of the respiratory drive and periodic breathing during the night [13]. Since the chemoreceptors can be triggered by inflammatory blood toxins, which accumulate in kidney failure [14], it is proposed that better clearance of these molecules can improve symptoms and outcomes of sleep apnoea. These molecules are poorly removed by standard haemodialysis [15] and are thought to cause the symptomatic effects of poor kidney function and inflammation, which are associated with poor sleep quality [16].
Better dialysis treatment may play an important role in the management of sleep apnoea. Previous studies have suggested that sleep apnoea may be improved by nocturnal dialysis; an intensive treatment which patients undergo at home, during sleep, for 8-10 hours every night. It provides better blood purification, compared with standard haemodialysis treatment. However, nocturnal dialysis is a home therapy which is not viable for the majority of haemodialysis patients who require care in a clinical setting. There is clearly a need to explore the effectiveness of dialysis treatment on sleep apnoea using a different dialysis model.
Modern dialysis technology, such as Haemodiafiltration (HDF), allows for better removal of toxic molecules such as beta 2 microglobulin (B2M) and C-Reactive protein (CRP), than standard haemodialysis treatment, and may offer the benefits of nocturnal dialysis to all dialysis patients. No one has examined the effect of HDF on sleep apnoea in haemodialysis patients, and the investigators will answer this question in this study.
Research Aims
- To determine the prevalence of sleep apnoea in the local dialysis population using a validated questionnaire and sleep study. Although sleep apnoea is recognised as common in the dialysis population, there is a need to reproduce this data in the context of local dialysis services to accurately identify affected patients
- To examine the effect of HDF compared conventional haemodialysis on health status and sleep quality in patients with sleep apnoea, using a randomised cross-over trial (RCT)
- To determine if the clearance of middle-sized uraemic toxins improves symptoms of sleep apnoea. The middle-sized molecules to be assessed in this study include C-Reactive protein (CRP), beta 2-microglobulin (β2M), tumour necrosis factor alpha (TNF-α), interleukin 6 (IL-6), and interleukin 8 (IL-8), which are the serum inflammatory markers that are commonly found in patients with obstructive sleep apnoea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Haemodialysis | Active comparator | Procedure: Haemodiafiltration post-dilution modelregular convectional haemodialysis 3times/weekly |
| Haemodiafiltration | Active comparator | Procedure: Haemodialysispost-dilution haemodiafiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haemodiafiltration post-dilution modelParticipants 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. | Procedure or surgery | Haemodialysis |
| HaemodialysisParticipants 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. | Procedure or surgery | Haemodiafiltration |
Primary outcome
Severity of Sleep Apnea measured by Apnea-hypopnea index
Time frame: 18 months
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.
4 secondary outcomes
Patient-reported sleep quality measured by PSQI
Time frame: 18 months
Patient-reported daytime sleepiness measured by ESS
Time frame: 18 months
Overall quality of life measured by KDQoL-36
Time frame: 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.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa McDonald, PhD principal investigator
Academic Clinician/University of Newcastle
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haemodiafiltration post-dilution model and Haemodialysis in people with Sleep Apnoea and Renal Failure, run by John Hunter Hospital at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Sleep Apnea measured by Apnea-hypopnea index (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.