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Completed

NCT Number: NCT00218790

The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"

A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University affiliated hemodialysis units, Atlanta, Georgia, United States

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About this study

Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. The major independent variable is dialysate temperature. The major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.

Exclusion criteria

  • Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level

Treatment and study plan

Cool dialysate

Procedure

Decreased temperature of the dialysis bath

Primary outcomes

  1. total sleep time

    Time frame: 9months

    amount of time slept per night

Secondary outcomes

  1. quality of life

    Time frame: 9 months

    Quality of life as defined by the Ferrans and Powers QOL Inventory

Other outcomes

  1. Comfort

    Time frame: 9 months

    Self-reported comfort as measured by a Likert scale

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

The Effects of Hemodialysis on the Sleep/Wake Cycle

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2005
Registry last updated
Feb 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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