BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients (BEDTIME)
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|ClinicalTrials.gov Identifier: NCT02825589|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure Chronic Requiring Hemodialysis Poor Quality Sleep||Device: BIA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Bioelectrical Impedance Analysis-Guided Comparing With Standard Clinical-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||February 2017|
Assessment of target dry weight guided by using bioelectrical impedance analysis (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.
- Change of sleep actigraphy parameters [ Time Frame: 6 months ]total sleep time, sleep efficiency, fragmentation index
- 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.
- Change of left ventricular mass index by echocardiography [ Time Frame: 6 months ]
- Change of ambulatory blood pressure monitoring [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825589
|Ramathibodi hospital, Mahidol university|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Arkom Nongnuch, MD||Ramathibodi Hospital|