Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure
NCT ID: NCT00380848
Last Updated: 2007-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2006-03-31
2007-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Interventions
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Hemodiafiltration
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gambro Renal Products, Inc.
INDUSTRY
McGill University
OTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Principal Investigators
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Kateri A Champagne, M.D.
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Navdeep Tangri, M.D.
Role: PRINCIPAL_INVESTIGATOR
McGill University
John R Kimoff, M.D.
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Paul Barre, M.D.
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sameena Iqbal, M.D.
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Royal Victoria Hospital - Dialysis Unit
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MUHC BMB 05-009
Identifier Type: -
Identifier Source: org_study_id