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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sleep Disorders in Chronic Kidney Disease Patients

NCT05240261

Chronic Kidney Diseases

UNKNOWN PHASE1

Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois

NCT00817492

Chronic Kidney Disease

COMPLETED

Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

NCT00817427

Chronic Kidney Disease

COMPLETED NA

Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults

NCT05780983

Insomnia Disorder

COMPLETED NA

Napping, Sleep, Cognitive Decline and Risk of Alzheimer's Disease

NCT03256539

Sleep Alzheimer Disease Cognitive Impairment +2 more

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

The control group received standard dialysis at a temperature of 37 degrees Celcius

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

Subjects in the experimental group received cool dialysate during treatment

Group Type EXPERIMENTAL

Cool Dialysate

Intervention Type PROCEDURE

Decreased temperature of the dialysis bath

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cool Dialysate

Decreased temperature of the dialysis bath

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No