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

March 6, 2019 updated by: Mahidol University

Effect of Bioelectrical Impedance Analysis-Guided Comparing With Standard Clinical-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • bed ridden status
  • alteration of consciousness
  • unstable hemodynamics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of sleep actigraphy parameters
Time Frame: 6 months
total sleep time, sleep efficiency, fragmentation index
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Change of left ventricular mass index by echocardiography
Time Frame: 6 months
6 months
Change of ambulatory blood pressure monitoring
Time Frame: 6 months
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Arkom Nongnuch, MD, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 3, 2016

First Submitted That Met QC Criteria

July 3, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID05-59-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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