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Completed

NCT Number: NCT02825589

BIA-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi hospital, Mahidol university

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • bed ridden status
  • alteration of consciousness
  • unstable hemodynamics

Treatment and study plan

BIA

Device

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.

Primary outcomes

  1. Change of sleep actigraphy parameters

    Time frame: 6 months

    total sleep time, sleep efficiency, fragmentation index

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: BEDTIME

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2016
Registry last updated
Mar 8, 2019

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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