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

NCT00380848 | Unknown

• 1 other identifier: MUHC BMB 05-009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; End Stage Renal Disease

Keywords

sleep apnea; end stage renal disease; hemodiafiltration

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

• 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

Interventions

Hemodiafiltration PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Gambro Renal Products, Inc.: collaborator
• McGill University: collaborator

Study Sites (1)

Royal Victoria Hospital - Dialysis Unit

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Kidney Failure, Chronic

Interventions

Hemodiafiltration

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Hemofiltration; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Barber, R.N.

CONTACT

514-934-1934; charlene.barber@muhc.mcgill.ca

Kateri Champagne, M.D.

CONTACT

514-934-1934; kateri.champagne@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: March 1, 2006
• Study Completion: December 1, 2007
• Last Updated: April 12, 2007

Record last verified: 2006-05

Locations

CA (1)