Renal Failure Chronic Requiring HemodialysisNCT02583347
Sleep Disturbance in Patients With End-Stage Renal Disease
An observational study of Renal Failure Chronic Requiring Hemodialysis and Sleep Disorders, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis, Sleep Disorders
- What is being tested?
- Vivia Home Hemodialysis System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2015to Jul 2018
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sixty consecutive patients will be enrolled in the study over a period of 24 months. Patients were prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality was planned.
Who may be able to join
- >16 years old,
- competent to independently undertake the informed consent process
- currently on RRT or planned to start RRT in the next three months.
Who cannot join
- Patients consuming Benzodiazepine medication
- Patients requiring nasal CPAP for sleep apnoea
- Patients requiring supplemental oxygen
- Patients with dementia, malignancy, or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital
Dublin, 00
Claire Kennedy, MB BCh BAO, 00353 1 8093000, clairekennedy2@beaumont.ie
About this study
Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients.
Project Aims
Read more
The aims of this project were three-fold:
- To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD
- To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort
- To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD
Read the detailed description
Patients will not selected based on presence/absence of sleep disturbance. Patients will be prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality is planned.
Patients will be selected for inclusion if they were >16 years old, competent to independently undertake the informed consent process and are currently on RRT or planned to start RRT in the next three months. The following exclusion criteria will be applied: dementia, active malignancy, major psychiatric disorder, home oxygen therapy, CPAP therapy, and regular benzodiazepine use.
Baseline Evaluation
Baseline evaluation includes the following:
- Demographics and clinical parameters including medications and caffeine intake
- Dialysis prescription and adequacy (weekly standardised Kt/V)
- Laboratory data (haemoglobin, iron, phosphate, PTH)
- Subjective sleep quality as measured by Berlin Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and International Restless Leg Syndrome Questionnaire
- Quality of Life as assessed by the 36 Item Short Form Survey (SF-36), Beck Depression Index and Centre for Epidemiologic Studies-Depression Scale
- Cognitive assessment as measured by Trail Making Tests 1 \& 2, Category Fluency, Controlled Oral Word Association Test and Hopkins Verbal Learning Test
- Unattended home polysomnography set-up up by investigator who was blinded to the results of the above assessments
- Wrist actigraphy for 3-5 continuous days (Philips Respironics Actiwatch 2 System)
Follow-up Evaluation following RRT Modality Change Follow-up evaluation will be performed in the same way as baseline evaluation at three - six months post switch of RRT modality. As the impact of NHHD is of particular interest, follow-up evaluation will be performed at one and six months post switch to NHHD in those patients who switched to NHHD. The follow-up home PSG was performed on an 'on-dialysis' night and an 'off-dialysis' night to evaluate the impact of the nocturnal procedure itself on sleep.
Data Analysis A sleep technician, blinded to the questionnaire results, compiles the PSG analysis and reports in accordance with the American Academy of Sleep Medicine (AASM) manual for the Scoring of Sleep and Associated Events (40). Actigraphy analysis is reported using Philips Respironics Actiwatch Software.
Statistical methods Statistical analysis will be performed using Stata V14 and Prism V6. All p values <0.05 will be considered statistically significant. Mean data and standard deviation data will be analysed using independent samples t-test and repeated measures analysis of variance (ANOVA). Nominal data will be analysed using chi-squared analysis.
Safety \& Tolerability Reports were reviewed with a Respiratory Consultant with specialist interest in Sleep Medicine on a regular basis and abnormal results were discussed in detail. If specific therapy is indicated on the basis of the research tests, the treating nephrologist will be informed and a management plan recommended.
- Being tested
- Vivia Home Hemodialysis System
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivia Home Hemodialysis SystemDevice
The cohort of interest is those patients performing nocturnal home hemodialysis using the Vivia Home Hemodialysis System for 8 hours, 5 nights per week
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD
from the total sample population of 60
Measured: 18 months
Secondary outcomes (2)
Change in Subjective Sleep Quality following change of RRT modality
Subjective sleep quality based on validated questionnaire
Measured: 6 months
Change in objective sleep quality following change of RRT modality
Objective sleep quality is measured by means of unattended home polysomnography for one night or wrist actigraphy for 3-5 consecutive nights
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Claire Kennedy, Beaumont Hospital
- Investigators
- Peter J Conlon, MB, MHS, Study director, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583347
- Sponsor's protocol ID
- BH-15/36
- Status last verified
- Aug 2017
- First submitted
- 14 Oct 2015
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Roumelioti ME, Brown LK, Unruh ML. The Relationship Between Volume Overload in End-Stage Renal Disease and Obstructive Sleep Apnea. Semin Dial. 2015 Sep-Oct;28(5):508-13. doi: 10.1111/sdi.12389. Epub 2015 May 5.
PubMed 25940851Loewen A, Siemens A, Hanly P. Sleep disruption in patients with sleep apnea and end-stage renal disease. J Clin Sleep Med. 2009 Aug 15;5(4):324-9.
PubMed 19968009Hanly P. Sleep disorders and home dialysis. Adv Chronic Kidney Dis. 2009 May;16(3):179-88. doi: 10.1053/j.ackd.2009.02.004.
PubMed 19393968Mallamaci F, Leonardis D, Tripepi R, Parlongo G, Catalano C, Tripepi G, Castronovo V, Ferini-Strambi L, Zoccali C. Sleep disordered breathing in renal transplant patients. Am J Transplant. 2009 Jun;9(6):1373-81. doi: 10.1111/j.1600-6143.2009.02653.x. Epub 2009 May 20.
PubMed 19459802Tang SC, Lam B, Lai AS, Pang CB, Tso WK, Khong PL, Ip MS, Lai KN. Improvement in sleep apnea during nocturnal peritoneal dialysis is associated with reduced airway congestion and better uremic clearance. Clin J Am Soc Nephrol. 2009 Feb;4(2):410-8. doi: 10.2215/CJN.03520708. Epub 2008 Dec 31.
PubMed 19118118Hanly PJ, Pierratos A. Improvement of sleep apnea in patients with chronic renal failure who undergo nocturnal hemodialysis. N Engl J Med. 2001 Jan 11;344(2):102-7. doi: 10.1056/NEJM200101113440204.
PubMed 11150360
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance in Patients With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT02583347
- Acronym / sponsor ID
- BH-15/36
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 22 Oct 2015 (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 disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients.
Project Aims
The aims of this project were three-fold:
- To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD
- To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort
- To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD
Detailed description
Patients will not selected based on presence/absence of sleep disturbance. Patients will be prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality is planned.
Patients will be selected for inclusion if they were >16 years old, competent to independently undertake the informed consent process and are currently on RRT or planned to start RRT in the next three months. The following exclusion criteria will be applied: dementia, active malignancy, major psychiatric disorder, home oxygen therapy, CPAP therapy, and regular benzodiazepine use.
Baseline Evaluation
Baseline evaluation includes the following:
- Demographics and clinical parameters including medications and caffeine intake
- Dialysis prescription and adequacy (weekly standardised Kt/V)
- Laboratory data (haemoglobin, iron, phosphate, PTH)
- Subjective sleep quality as measured by Berlin Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and International Restless Leg Syndrome Questionnaire
- Quality of Life as assessed by the 36 Item Short Form Survey (SF-36), Beck Depression Index and Centre for Epidemiologic Studies-Depression Scale
- Cognitive assessment as measured by Trail Making Tests 1 \& 2, Category Fluency, Controlled Oral Word Association Test and Hopkins Verbal Learning Test
- Unattended home polysomnography set-up up by investigator who was blinded to the results of the above assessments
- Wrist actigraphy for 3-5 continuous days (Philips Respironics Actiwatch 2 System)
Follow-up Evaluation following RRT Modality Change Follow-up evaluation will be performed in the same way as baseline evaluation at three - six months post switch of RRT modality. As the impact of NHHD is of particular interest, follow-up evaluation will be performed at one and six months post switch to NHHD in those patients who switched to NHHD. The follow-up home PSG was performed on an 'on-dialysis' night and an 'off-dialysis' night to evaluate the impact of the nocturnal procedure itself on sleep.
Data Analysis A sleep technician, blinded to the questionnaire results, compiles the PSG analysis and reports in accordance with the American Academy of Sleep Medicine (AASM) manual for the Scoring of Sleep and Associated Events (40). Actigraphy analysis is reported using Philips Respironics Actiwatch Software.
Statistical methods Statistical analysis will be performed using Stata V14 and Prism V6. All p values <0.05 will be considered statistically significant. Mean data and standard deviation data will be analysed using independent samples t-test and repeated measures analysis of variance (ANOVA). Nominal data will be analysed using chi-squared analysis.
Safety \& Tolerability Reports were reviewed with a Respiratory Consultant with specialist interest in Sleep Medicine on a regular basis and abnormal results were discussed in detail. If specific therapy is indicated on the basis of the research tests, the treating nephrologist will be informed and a management plan recommended.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sixty consecutive patients will be enrolled in the study over a period of 24 months. Patients were prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality was planned.
Key inclusion criteria (3 listed)
- >16 years old,
- competent to independently undertake the informed consent process
- currently on RRT or planned to start RRT in the next three months.
Key exclusion criteria (4 listed)
- Patients consuming Benzodiazepine medication
- Patients requiring nasal CPAP for sleep apnoea
- Patients requiring supplemental oxygen
- Patients with dementia, malignancy, or psychiatric disorder
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 |
|---|---|---|
| Vivia Home Hemodialysis SystemThe cohort of interest is those patients performing nocturnal home hemodialysis using the Vivia Home Hemodialysis System for 8 hours, 5 nights per week | Device | – |
Primary outcome
The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD
Time frame: 18 months
from the total sample population of 60
2 secondary outcomes
Change in Subjective Sleep Quality following change of RRT modality
Time frame: 6 months
Change in objective sleep quality following change of RRT modality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 25940851Roumelioti ME, Brown LK, Unruh ML. The Relationship Between Volume Overload in End-Stage Renal Disease and Obstructive Sleep Apnea. Semin Dial. 2015 Sep-Oct;28(5):508-13. doi: 10.1111/sdi.12389. Epub 2015 May 5.
- Background: PubMed 19968009Loewen A, Siemens A, Hanly P. Sleep disruption in patients with sleep apnea and end-stage renal disease. J Clin Sleep Med. 2009 Aug 15;5(4):324-9.
- Background: PubMed 19393968Hanly P. Sleep disorders and home dialysis. Adv Chronic Kidney Dis. 2009 May;16(3):179-88. doi: 10.1053/j.ackd.2009.02.004.
- Background: PubMed 19459802Mallamaci F, Leonardis D, Tripepi R, Parlongo G, Catalano C, Tripepi G, Castronovo V, Ferini-Strambi L, Zoccali C. Sleep disordered breathing in renal transplant patients. Am J Transplant. 2009 Jun;9(6):1373-81. doi: 10.1111/j.1600-6143.2009.02653.x. Epub 2009 May 20.
- Background: PubMed 19118118Tang SC, Lam B, Lai AS, Pang CB, Tso WK, Khong PL, Ip MS, Lai KN. Improvement in sleep apnea during nocturnal peritoneal dialysis is associated with reduced airway congestion and better uremic clearance. Clin J Am Soc Nephrol. 2009 Feb;4(2):410-8. doi: 10.2215/CJN.03520708. Epub 2008 Dec 31.
- Background: PubMed 11150360Hanly PJ, Pierratos A. Improvement of sleep apnea in patients with chronic renal failure who undergo nocturnal hemodialysis. N Engl J Med. 2001 Jan 11;344(2):102-7. doi: 10.1056/NEJM200101113440204.
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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.
Peter J Conlon, MB, MHS study director
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Chronic Requiring Hemodialysis and Sleep Disorders, run by Beaumont Hospital at 1 site in Ireland.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire M Kennedy, MB, BMedSci (00353 1 8093000 ext. 739, clairekennedy2@beaumont.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583347, which also lists 6 linked publications.
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 28 Aug 2017.