Sleep Disturbance in Patients With End-Stage Renal Disease

August 25, 2017 updated by: Claire Kennedy, Beaumont Hospital

Sleep disorders are common in patients who have chronic kidney disease (CKD). Insomnia is reported in up to 50% of patients treated with hemodialysis compared to 12% of a control population. Restless leg syndrome (RLS) and periodic limb movement disorder (PLM) have been described in 30 to 70% of patients with end stage kidney disease (ESKD). Patients with CKD have also been reported to have a very high prevalence of sleep apnoea disorder. Conventional hemodialysis and peritoneal dialysis do not appear to improve sleep disorders in patients with CKD. There is emerging evidence that nocturnal HD can lead to improvements in sleep quality. Transplantation is thought to improve sleep-related disorders in some but not all patients.

Project Aims

The aims of this project were three-fold:

  1. To perform detailed assessment of sleep quality in a cohort of Irish patients with ESRD
  2. To assess the feasability and tolerability of unattended home PSG and wrist actigraphy as diagnostic tools in this cohort
  3. To assess the impact of a change in RRT modality on sleep quality in Irish patients with ESRD

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will not selected based on presence/absence of sleep disturbance. Patients will be prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality is planned.

Patients will be selected for inclusion if they were >16 years old, competent to independently undertake the informed consent process and are currently on RRT or planned to start RRT in the next three months. The following exclusion criteria will be applied: dementia, active malignancy, major psychiatric disorder, home oxygen therapy, CPAP therapy, and regular benzodiazepine use.

Baseline Evaluation

Baseline evaluation includes the following:

  • Demographics and clinical parameters including medications and caffeine intake
  • Dialysis prescription and adequacy (weekly standardised Kt/V)
  • Laboratory data (haemoglobin, iron, phosphate, PTH)
  • Subjective sleep quality as measured by Berlin Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and International Restless Leg Syndrome Questionnaire
  • Quality of Life as assessed by the 36 Item Short Form Survey (SF-36), Beck Depression Index and Centre for Epidemiologic Studies-Depression Scale
  • Cognitive assessment as measured by Trail Making Tests 1 & 2, Category Fluency, Controlled Oral Word Association Test and Hopkins Verbal Learning Test
  • Unattended home polysomnography set-up up by investigator who was blinded to the results of the above assessments
  • Wrist actigraphy for 3-5 continuous days (Philips Respironics Actiwatch 2 System)

Follow-up Evaluation following RRT Modality Change Follow-up evaluation will be performed in the same way as baseline evaluation at three - six months post switch of RRT modality. As the impact of NHHD is of particular interest, follow-up evaluation will be performed at one and six months post switch to NHHD in those patients who switched to NHHD. The follow-up home PSG was performed on an 'on-dialysis' night and an 'off-dialysis' night to evaluate the impact of the nocturnal procedure itself on sleep.

Data Analysis A sleep technician, blinded to the questionnaire results, compiles the PSG analysis and reports in accordance with the American Academy of Sleep Medicine (AASM) manual for the Scoring of Sleep and Associated Events (40). Actigraphy analysis is reported using Philips Respironics Actiwatch Software.

Statistical methods Statistical analysis will be performed using Stata V14 and Prism V6. All p values <0.05 will be considered statistically significant. Mean data and standard deviation data will be analysed using independent samples t-test and repeated measures analysis of variance (ANOVA). Nominal data will be analysed using chi-squared analysis.

Safety & Tolerability Reports were reviewed with a Respiratory Consultant with specialist interest in Sleep Medicine on a regular basis and abnormal results were discussed in detail. If specific therapy is indicated on the basis of the research tests, the treating nephrologist will be informed and a management plan recommended.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sixty consecutive patients will be enrolled in the study over a period of 24 months. Patients were prioritized for recruitment if they were active on the transplant waitlist or a change in RRT modality was planned.

Description

Inclusion Criteria:

  • >16 years old,
  • competent to independently undertake the informed consent process
  • currently on RRT or planned to start RRT in the next three months.

Exclusion Criteria:

  • Patients consuming Benzodiazepine medication
  • Patients requiring nasal CPAP for sleep apnoea
  • Patients requiring supplemental oxygen
  • Patients with dementia, malignancy, or psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of sleep disorders in a cohort of patients with advanced CKD/ESRD
Time Frame: 18 months
from the total sample population of 60
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Sleep Quality following change of RRT modality
Time Frame: 6 months
Subjective sleep quality based on validated questionnaire
6 months
Change in objective sleep quality following change of RRT modality
Time Frame: 6 months
Objective sleep quality is measured by means of unattended home polysomnography for one night or wrist actigraphy for 3-5 consecutive nights
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beaumont Hospital

Collaborators

Baxter Healthcare Corporation

Investigators

  • Study Director: Peter J Conlon, MB, MHS, Beaumont Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH-15/36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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