Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure
Primary Purpose
Sleep Apnea, End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hemodiafiltration
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, end stage renal disease, hemodiafiltration
Eligibility 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
Sites / Locations
- Royal Victoria Hospital - Dialysis UnitRecruiting
Outcomes
Primary Outcome Measures
Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00380848
First Posted
September 25, 2006
Last Updated
April 11, 2007
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Gambro Renal Products, Inc., McGill University
1. Study Identification
Unique Protocol Identification Number
NCT00380848
Brief Title
Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure
Official Title
Effect of Hemodiafiltration on Sleep-Disordered Breathing in Patients With End-Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Gambro Renal Products, Inc., McGill University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, End Stage Renal Disease
Keywords
sleep apnea, end stage renal disease, hemodiafiltration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hemodiafiltration
Primary Outcome Measure Information:
Title
Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
Secondary Outcome Measure Information:
Title
Generic Quality of life
Title
specific quality of life related to sleep apnea
Title
specific quality of life related to Restless leg syndrome
Title
24 hour blood pressure control
Title
Periodic limb movement indices
Title
Validity of a positive screening sleep study
Title
specific quality of life related to sleep
Title
Upper airway neuronal afferent dysfunction
Title
Relationship between cytokine levels and sleep apnea severity
Title
Relationship between dialysis clearance and sleep apnea severity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlene Barber, R.N.
Phone
514-934-1934
Ext
36764
Email
charlene.barber@muhc.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kateri Champagne, M.D.
Phone
514-934-1934
Ext
35650
Email
kateri.champagne@muhc.mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kateri A Champagne, M.D.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Navdeep Tangri, M.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John R Kimoff, M.D.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Barre, M.D.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sameena Iqbal, M.D.
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Victoria Hospital - Dialysis Unit
City
Montreal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Barber, RN
Phone
(514) 934-1934
Ext
36764
Email
charlene.barber@muhc.mcgill.ca
12. IPD Sharing Statement
Learn more about this trial
Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure
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