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

Study Overview
=================
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.

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

Conditions
-----------------
Renal Failure Chronic Requiring Hemodialysis, Poor Quality Sleep

Intervention / Treatment
-----------------
* Device: BIA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular hemodialysis 3 times/week PSQI score >5 Subclinical hypervolemia Exclusion Criteria: bed ridden status alteration of consciousness unstable hemodynamics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIA-guided<br>Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA). | Device: BIA<br>* 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.<br>|
| No Intervention: Standard clinical guided<br>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 | total sleep time, sleep efficiency, fragmentation index | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of PSQI scores | 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 |  | 6 months | 
| Change of ambulatory blood pressure monitoring |  | 6 months | 
| Cardiovascular complications | complications which can occur from overestimate of ultrafiltration eg. intradialytic hypotension, arrhythmia, cerebral vascular events, myocardial ischemic events etc. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIA, chronic hemodialysis, sleep quality