Sleep ApneaNCT00380848
Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure
A study testing Hemodiafiltration in people with Sleep Apnea and End Stage Renal Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, End Stage Renal Disease
- What is being tested?
- Hemodiafiltration
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Dec 2007
- Phase
- Interventional
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
- Patients currently stable on a thrice weekly hemodialysis regimen for a minimum of 3 months
- Patients with vascular access and no contraindications to anticoagulation
- Presence of sleep-related breathing disorder defined as a mean apnea-hypopnea per hour of recording greater than 10 based on cardiorespiratory monitoring
Who cannot join
- Patients already on hemodiafiltration therapy
- Patients already on treatment for sleep disordered breathing.
- Patients with significant neuromuscular disease
- Patients with an expected lifespan < 1 year
- Patients unable to complete sleep related quality of life questionnaires and consent forms due to language barriers or dementia
- Patients with known substance abuse
- Patients with a respiratory disturbance index greater than 30 with active cardiovascular disease defined by unstable angina, myocardial infarction within 3 months or an Epworth sleepiness score greater than 15 while actively working in a stress situation (for example bus driver, taxi driver). These patients will be evaluated by a sleep specialist.
- Living further than 30 km from dialysis centre
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Victoria Hospital - Dialysis Unit
Montreal, Quebec
Charlene Barber, RN, (514) 934-1934 ext. 36764, charlene.barber@muhc.mcgill.ca
About this study
Official title: Effect of Hemodiafiltration on Sleep-Disordered Breathing in Patients With End-Stage Renal Disease
The purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease.
Read the detailed description
Sleep apnea or breathing problems during sleep are frequent, occurring in 6% of the general population. However, more than half of all patients on dialysis suffer from breathing problems related to sleep. Sleep apnea is associated with high blood pressure, excessive sleepiness, fatigue, poor memory and concentration as well as depression in those with normal kidneys.
Hemodiafiltration is a new kind of dialysis that is more efficient at clearing toxins that accumulate in kidney failure. It has been used successfully in Europe for over 15 years. However, the effects of hemodiafiltration on sleep apnea in dialysis patients have never been assessed.
We are conducting a clinical trial to examine the effects of hemodiafiltration on sleep apnea in dialysis patients. Fifteen patients with sleep apnea, already on dialysis will be treated with hemodiafiltration 3 times a week, instead of their regular hemodialysis treatment for a period of 3 months. We will repeat sleep studies in these patients before and after the hemodiafiltration period and assess their quality of life.
We hope to decrease the severity of sleep apnea with hemodiafiltration. This could result in better sleep, improved energy level, mood, memory, concentration and blood pressure control in those afflicted by sleep apnea and on dialysis. Our findings would also give us better insight into the cause of sleep apnea in patients with end stage kidney disease.
- Conditions
- Sleep Apnea, End Stage Renal Disease
- Being tested
- Hemodiafiltration
- Keywords
- sleep apnea, end stage renal disease, hemodiafiltration
- Medical subject headings
- Sleep Apnea Syndromes, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodiafiltrationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
Secondary outcomes (10)
Generic Quality of life
specific quality of life related to sleep apnea
specific quality of life related to Restless leg syndrome
24 hour blood pressure control
Periodic limb movement indices
Validity of a positive screening sleep study
specific quality of life related to sleep
Upper airway neuronal afferent dysfunction
Relationship between cytokine levels and sleep apnea severity
Relationship between dialysis clearance and sleep apnea severity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startMar 2006
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Masking
- Single blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Renal Products, Inc., McGill University
- Investigators
- Kateri A Champagne, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreNavdeep Tangri, M.D., Principal investigator, McGill UniversityJohn R Kimoff, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentrePaul Barre, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreSameena Iqbal, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380848
- Sponsor's protocol ID
- MUHC BMB 05-009
- Status last verified
- May 2006
- First submitted
- 25 Sep 2006
- Last updated
- 12 Apr 2007
- Results posted
- No