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Effects of Hemodialysis on the Sleep/Wake Cycle

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00460863
First received: April 16, 2007
Last updated: May 6, 2008
Last verified: May 2008
History of Changes
  Purpose

The purpose of this study is to test a novel application of an existing treatment - using col dialysate (often used to treat hypotension) as opposed to warm dialysate (standard treatment) during hemodialysis for its ability to stabilize the sleep/wake cycle of patients receiving this chronic treatment


Condition Intervention Phase
End Stage Renal Disease
 Procedure: using cool versus warm dialysate during hemodialysis
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Hemodialysis on the Slee/Wake Cycle of Patients on Chronic Hemodialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Polysomnographic measures of sleep [ Time Frame: At three time points over the nine month study period ] [ Designated as safety issue: Yes ]
  • Polysomnographic measures of daytime sleepiness [ Time Frame: At three time points over the nine month study period ] [ Designated as safety issue: Yes ]
  • Distal/proximal skin temperature gradient [ Time Frame: At three time points during the nine month study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective measure of sleep quality [ Time Frame: Monthly during the nine month study period ] [ Designated as safety issue: No ]
  • Subjective measure of daytime sleepiness [ Time Frame: Monthly during the nine month study period ] [ Designated as safety issue: Yes ]
  • Subjective measure of mood [ Time Frame: Monthly during the nine month study period ] [ Designated as safety issue: No ]
  • Subjective measure of quality of life [ Time Frame: Monthly during the nine month study period ] [ Designated as safety issue: No ]
  • Subjective measure of functional health status [ Time Frame: Monthly during the nine month study period ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: April 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All races
  • Cause of renal failures - diabetes, hypertension, glomerulonephritis, or polycystic kidney disease
  • Ability to read and write in English hemodialysis three times a week for at least 4 months
  • Clinically stable
  • KT/V > 1.0
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460863

Locations
United States, Georgia
Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Kathy P Parker, PhD Emory University
  More Information

No publications provided

Responsible Party: Kathy P. Parker, Edith F. Honeycutt Professor, Emory University
ClinicalTrials.gov Identifier: NCT00460863     History of Changes
Other Study ID Numbers: 72728732, RO1 NR004340
Study First Received: April 16, 2007
Last Updated: May 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
sleep
hemodialysis
daytime sleepiness
temperature

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013