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Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure

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ClinicalTrials.gov Identifier: NCT00380848
Recruitment Status : Unknown
Verified May 2006 by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Recruiting
First Posted : September 27, 2006
Last Update Posted : April 12, 2007
Sponsor:
Collaborators:
Gambro Renal Products, Inc.
McGill University
Information provided by:
McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea End Stage Renal Disease Procedure: Hemodiafiltration Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Hemodiafiltration on Sleep-Disordered Breathing in Patients With End-Stage Renal Disease
Study Start Date : March 2006
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography

Secondary Outcome Measures :
  1. Generic Quality of life
  2. specific quality of life related to sleep apnea
  3. specific quality of life related to Restless leg syndrome
  4. 24 hour blood pressure control
  5. Periodic limb movement indices
  6. Validity of a positive screening sleep study
  7. specific quality of life related to sleep
  8. Upper airway neuronal afferent dysfunction
  9. Relationship between cytokine levels and sleep apnea severity
  10. Relationship between dialysis clearance and sleep apnea severity

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380848


Contacts
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Contact: Charlene Barber, R.N. 514-934-1934 ext 36764 charlene.barber@muhc.mcgill.ca
Contact: Kateri Champagne, M.D. 514-934-1934 ext 35650 kateri.champagne@muhc.mcgill.ca

Locations
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Canada, Quebec
Royal Victoria Hospital - Dialysis Unit Recruiting
Montreal, Quebec, Canada
Contact: Charlene Barber, RN    (514) 934-1934 ext 36764    charlene.barber@muhc.mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Gambro Renal Products, Inc.
McGill University
Investigators
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Principal Investigator: Kateri A Champagne, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Navdeep Tangri, M.D. McGill University
Principal Investigator: John R Kimoff, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Paul Barre, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Sameena Iqbal, M.D. McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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ClinicalTrials.gov Identifier: NCT00380848    
Other Study ID Numbers: MUHC BMB 05-009
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: April 12, 2007
Last Verified: May 2006
Keywords provided by McGill University Health Centre/Research Institute of the McGill University Health Centre:
sleep apnea
end stage renal disease
hemodiafiltration
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Kidney Diseases
Kidney Failure, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency