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

April 11, 2007 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Royal Victoria Hospital - Dialysis Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

McGill University
Gambro Renal Products, Inc.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

September 25, 2006

First Submitted That Met QC Criteria

September 25, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 12, 2007

Last Update Submitted That Met QC Criteria

April 11, 2007

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHC BMB 05-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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