Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Hemodialysis on the Sleep/Wake Cycle

This study has been completed.
Information provided by (Responsible Party):
Sandra B. Dunbar, RN, Emory University Identifier:
First received: April 16, 2007
Last updated: April 22, 2014
Last verified: May 2008

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:

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00460863

United States, Georgia
Nell Hodgson Woodruff School of Nursing
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Principal Investigator: Kathy P Parker, PhD Emory University
  More Information

No publications provided

Responsible Party: Sandra B. Dunbar, RN, Principal Investigator, Emory University Identifier: NCT00460863     History of Changes
Other Study ID Numbers: 0602-2002, RO1 NR004340, 72728732
Study First Received: April 16, 2007
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
daytime sleepiness

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases processed this record on March 03, 2015