Poor Quality Sleep, Renal Failure Chronic Requiring Hemodialysis
Conditions
Keywords
BIA, chronic hemodialysis, sleep quality
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.
Interventions
DEVICEBIA
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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* regular hemodialysis 3 times/week * PSQI score \>5 * Subclinical hypervolemia
Exclusion criteria
* bed ridden status * alteration of consciousness * unstable hemodynamics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of sleep actigraphy parameters | 6 months | total sleep time, sleep efficiency, fragmentation index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
Countries
Thailand
Outcome results
None listed