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
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea End Stage Renal Disease||Procedure: Hemodiafiltration||Not Applicable|
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 (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|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|
- Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
- 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
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
|Contact: Charlene Barber, R.N.||514-934-1934 ext firstname.lastname@example.org|
|Contact: Kateri Champagne, M.D.||514-934-1934 ext email@example.com|
|Royal Victoria Hospital - Dialysis Unit||Recruiting|
|Montreal, Quebec, Canada|
|Contact: Charlene Barber, RN (514) 934-1934 ext 36764 firstname.lastname@example.org|
|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|