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BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients (BEDTIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825589
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : March 8, 2019
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate whether more accurate dry weight assessment with BIA in these patients can lead to better sleep quality (measured by sleep actigraphy and questionnaires). The investigators will enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of consciousness and unstable hemodynamics will be excluded. Then eligible patients will be randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The investigators will assess participants' dry weight at beginning of study, 3rd month and 6th month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep questionnaires score, left ventricular mass index by echocardiography, ambulatory blood pressure monitoring and blood chemistry results were collected at beginning of study, the end of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters between the groups. The secondary outcomes are change of sleep questionnaires scores, change of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular complications between groups.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Requiring Hemodialysis Poor Quality Sleep Device: BIA Not Applicable

Detailed Description:
This randomized control trial aim to detect the better volume control guided by bioimpedance may improve ambulatory blood pressure control, sleep quality and left ventricular hypertrophy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Bioelectrical Impedance Analysis-Guided Comparing With Standard Clinical-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIA-guided
Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA).
Device: BIA
BIA or bioelectrical impedance analysis using electric current through body tissues to estimate body composition particularly body fat and total body water calculating to target body weight.

No Intervention: Standard clinical guided
Assessment of target dry weight guided by clinical evaluation eg. jugular venous pressure, blood pressure, edema etc.

Primary Outcome Measures :
  1. Change of sleep actigraphy parameters [ Time Frame: 6 months ]
    total sleep time, sleep efficiency, fragmentation index

Secondary Outcome Measures :
  1. Change of PSQI scores [ Time Frame: 6 months ]
    PSQI or Pittsburgh sleep Quality Index is an instrument for assessment subjective sleep quality in various group of patients.

  2. Change of left ventricular mass index by echocardiography [ Time Frame: 6 months ]
  3. Change of ambulatory blood pressure monitoring [ Time Frame: 6 months ]
  4. Cardiovascular complications [ Time Frame: 6 months ]
    complications which can occur from overestimate of ultrafiltration eg. intradialytic hypotension, arrhythmia, cerebral vascular events, myocardial ischemic events etc.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • regular hemodialysis 3 times/week
  • PSQI score >5
  • Subclinical hypervolemia

Exclusion Criteria:

  • bed ridden status
  • alteration of consciousness
  • unstable hemodynamics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02825589

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Ramathibodi hospital, Mahidol university
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Arkom Nongnuch, MD Ramathibodi Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mahidol University Identifier: NCT02825589    
Other Study ID Numbers: ID05-59-12
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mahidol University:
chronic hemodialysis
sleep quality
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic