Sleep Disorders in Chronic Kidney Disease Patients

February 4, 2022 updated by: Mona Abd Ellatif Aly Ismael, Assiut University

Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients

  1. Asses sleep disorders in CKD patients and those on haemodialysis and related complications ( uncontrolled blood pressure,glomerular filtration rate (GFR) ,proteinuria and psychological disturbance)
  2. Asses effect of hypnotics or sedations for 3 month in improvement those complications after taking treatment .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Sleep disorders are prevalent in patients with chronic kidney disease (CKD) in particular those with end stage renal disease (ESRD). It has been reported that 80% of ESRD patients receiving dialysis report sleep complaints, with daytime sleepiness to be the most common reported symptom. The reason for increased rates of sleep related issues and disorders in this population is likely multifactorial.

Although it is commonly accepted that patients with CKD experience poor sleep quality, not much is known about the physiological mechanisms underlying this phenomenon. Patients with CKD often exhibit sympatho-vagal imbalance due to baroreceptor reflex function impairment in which there is hyperactivity of the sympathetic nervous system and decreased vagal tone. In healthy individuals, sleep is accompanied by a decrease in sympathetic activity and an increase in vagal tone that leads to a nocturnal dipping of blood pressure. However, patients who have sleep disorders resulting in hypoxemia and sleep fragmentation have been shown to have increased sympathetic nervous system stimulation and decreased parasympathetic activity, which results in a reduced fall in nocturnal blood pressure.

In patients with ESRD, the identification, diagnosis and treatment of sleep disorders is complicated by the overlapping presentation with CKD and other commonly comorbid conditions. One approach to conceptualizing this relationship is to consider sleep disorders as secondary or end product of multiple concurrent and interactive processes. Such processes include psychological disorders (depression, anxiety), lifestyle factors (coffee/nicotine use, sleep hygiene), treatment-related factors (timing of dialysis, daytime napping, production of cytokines, thermoregulatory changes, dialysis disequilibrium syndrome, disruptions in circadian rhythm, medication side effects) as well as intrinsic, ESRD-specific factors (anemia/obstructive sleep apnea (OSA) and other comorbidities, uremia, overall all health and quality of life, alterations in neurotransmitter production).

A poor sleep profile is associated with increased risk of CKD development. Therefore, sleep duration and quality should be considered when developing strategies to improve sleep and thus prevent CKD.

Poor sleep quality, which is commonly found in pre-dialysis CKD patients, is an independent factor associated with cardiovascular damage in CKD patients.

Both short and long sleep durations are significantly associated with CKD and proteinuria. Some findings suggest curvilinear dose-response associations of sleep duration with CKD and proteinuria.

Optimizing sleep quality and duration to >6 h/night improved BP control and was associated with a significant delta change in systolic blood pressure (SBP) within 3 months of follow-up. Physicians should obtain a sleep history in patients with CKD who present with resistant hypertension.

Poor sleep quality is prevalent in patients on maintenance haemodialysis, and is associated with increased daytime sleepiness. Depression further compounds this relationship, and is significantly associated with increased daytime sleepiness and restless leg syndrome.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

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 Backup

  • Name: Ashraf Mohammed Elshazly
  • Phone Number: 00201069176881

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.patients are between ages 18 and 60 with chronic kidney disease (CKD)( stage III-V) and ESRD Patients on regular haemodialysis > 6 months.and time of start session of dialysis at 5 pm , thrice weekly .

    2. Random urine albumin/creatinine ratio of 30 mcg/day or greater (protein in the urine) 3. Patients have ability to complete a sleep survey and must be able to swallow tablets.

    4. Patients with compensated heart and liver disease. 5. Not on antipsychotic drugs.

Exclusion Criteria:

  1. Patients with history of psychosis.
  2. Patients with decompensated heart or liver disease.
  3. Patients with diabetes , autoimmune ,thyroid or neurological disorders.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ESRAD on regular haemodialysis
30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month.
Drug: Quetiapine
Quetiapine 25 mg / day
Other: CKD patients (predialydsis)
30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month.
Drug: Quetiapine
Quetiapine 25 mg / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- change in Blood pressure measurement .
Time Frame: 3 months
follow up blood pressure ( millimeters of mercury (mm/hg)
3 months
The Quality of Life Scale (QOLS)
Time Frame: 3 months
Scores can range from 16 to 112. higher scores indicate better life quality.
3 months
Pittsburgh Sleep Quality Index score (PSQI S).
Time Frame: 3 months
Scale 0-21, higher scores indicate worse sleep quality.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
proteinuria
Time Frame: 3 months
3 months
change in Estimated Glomerular filteration rate.
Time Frame: 3 month
3 month

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 2, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic kidney disease (CKD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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