Clinical trial NCT00380848: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
End Stage Renal Disease
Keywords: sleep apnea
end stage renal disease
hemodiafiltration
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Gambro Renal Products, Inc.
name: McGill University
First posted: 2006-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
Secondary outcomes:
measure: Generic Quality of life
measure: specific quality of life related to sleep apnea
measure: specific quality of life related to Restless leg syndrome
measure: 24 hour blood pressure control
measure: Periodic limb movement indices
measure: Validity of a positive screening sleep study
measure: specific quality of life related to sleep
measure: Upper airway neuronal afferent dysfunction
measure: Relationship between cytokine levels and sleep apnea severity
measure: Relationship between dialysis clearance and sleep apnea severity
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital - Dialysis Unit
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Kateri A Champagne, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Navdeep Tangri, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: John R Kimoff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Paul Barre, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sameena Iqbal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: