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

Poor Quality Sleep Clinical Trial

— BEDTIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825589
• Other study ID #: ID05-59-12
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• regular hemodialysis 3 times/week

• PSQI score >5

• Subclinical hypervolemia

Exclusion Criteria:

• bed ridden status

• alteration of consciousness

• unstable hemodynamics

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Poor Quality Sleep
• Renal Failure Chronic Requiring Hemodialysis
• Renal Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Thailand	Ramathibodi hospital, Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of sleep actigraphy parameters	total sleep time, sleep efficiency, fragmentation index	6 months
Secondary	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
Secondary	Change of left ventricular mass index by echocardiography		6 months
Secondary	Change of ambulatory blood pressure monitoring		6 months
Secondary	Cardiovascular complications	complications which can occur from overestimate of ultrafiltration eg. intradialytic hypotension, arrhythmia, cerebral vascular events, myocardial ischemic events etc.	6 months