Clinical trial NCT02825589: BIA-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients
Official title: Effect of Bioelectrical Impedance Analysis-Guided Comparing With Standard Clinical-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Poor Quality Sleep
Keywords: BIA
chronic hemodialysis
sleep quality
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* bed ridden status
* alteration of consciousness
* unstable hemodynamics

Primary outcomes:
measure: Change of sleep actigraphy parameters
timeFrame: 6 months
Secondary outcomes:
measure: Change of PSQI scores
timeFrame: 6 months
measure: Change of left ventricular mass index by echocardiography
timeFrame: 6 months
measure: Change of ambulatory blood pressure monitoring
timeFrame: 6 months
measure: Cardiovascular complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi hospital, Mahidol university
Study officials:
affiliation: Ramathibodi Hospital
name: Arkom Nongnuch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sethakarun S, Bijaphala S, Kitiyakara C, Boongird S, Phanachet P, Reutrakul S, Pirojsakul K, Nongnuch A. Effect of bioelectrical impedance analysis-guided dry weight adjustment, in comparison to standard clinical-guided, on the sleep quality of chronic haemodialysis patients (BEDTIME study): a randomised controlled trial. BMC Nephrol. 2019 Sep 2;20(1):211. doi: 10.1186/s12882-019-1405-z.