NCT02825589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

July 3, 2016

Last Update Submit

March 6, 2019

Conditions

Renal Failure Chronic Requiring HemodialysisPoor Quality Sleep

Keywords

BIAchronic hemodialysissleep quality

Outcome Measures

Primary Outcomes (1)

  • Change of sleep actigraphy parameters

    total sleep time, sleep efficiency, fragmentation index

    6 months

Secondary Outcomes (4)

  • Change of PSQI scores

    6 months

  • Change of left ventricular mass index by echocardiography

    6 months

  • Change of ambulatory blood pressure monitoring

    6 months

  • Cardiovascular complications

    6 months

Study Arms (2)

BIA-guided

EXPERIMENTAL

Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA).

Device: BIA

Standard clinical guided

NO INTERVENTION

Assessment of target dry weight guided by clinical evaluation eg. jugular venous pressure, blood pressure, edema etc.

Interventions

BIADEVICE

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.

BIA-guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • bed ridden status
  • alteration of consciousness
  • unstable hemodynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi hospital, Mahidol university

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 31474223DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Arkom Nongnuch, MD

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

March 8, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)