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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beaumont Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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