Recruiting

Dialysis & Sleep ApneaImpact of Different Dialysis on Sleep Apnea in Patients With Renal Failure

Sponsor:

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

Code:

NCT00380848

Conditions

Sleep Apnea

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hemodiafiltration

Study Details

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

Study ID

NCT00380848

Start date

Mar, 2006

Status verified date

May, 2006

Completion date

Dec, 2007

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Hemodiafiltration

Primary outcome measure

Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Charlene Barber, R.N.

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

Kateri Champagne, M.D.

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

Locations

Royal Victoria Hospital - Dialysis Unit

Recruiting

Montreal, Quebec, Canada

Contacts

Charlene Barber, RN

(514) 934-1934 charlene.barber@muhc.mcgill.ca

More Information

Sponsor

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

Last update posted

Apr 12, 2007

Last verified

May, 2006

Keywords

sleep apnea
end stage renal disease
hemodiafiltration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2007-04-12.