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

Not Applicable

Completed

• Conditions: Renal Failure Chronic Requiring Hemodialysis; Poor Quality Sleep
• Interventions: Device: BIA

• Registration Number: NCT02825589
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-03
• Study First Submitted QC: 2016-07-03
• Study First Posted: 2016-07-07
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

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

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Exclusion Criteria

• bed ridden status
• alteration of consciousness
• unstable hemodynamics

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIA-guided	BIA	Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA).

Primary Outcome Measures

Name	Time	Method
Change of sleep actigraphy parameters	6 months	total sleep time, sleep efficiency, fragmentation index

Secondary Outcome Measures

Name	Time	Method
Change of ambulatory blood pressure monitoring	6 months
Cardiovascular complications	6 months	complications which can occur from overestimate of ultrafiltration eg. intradialytic hypotension, arrhythmia, cerebral vascular events, myocardial ischemic events etc.
Change of PSQI scores	6 months	PSQI or Pittsburgh sleep Quality Index is an instrument for assessment subjective sleep quality in various group of patients.
Change of left ventricular mass index by echocardiography	6 months

Trial Locations

Locations (1)

Ramathibodi hospital, Mahidol university; 🇹🇭 Bangkok, Thailand