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Sleep Disorders in Chronic Kidney Disease Patients

Primary Purpose

Chronic Kidney Diseases

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    ESRAD on regular haemodialysis

    CKD patients (predialydsis)

    Arm Description

    30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month.

    30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    change in Estimated Glomerular filteration rate.
    proteinuria

    Full Information

    First Posted
    January 2, 2022
    Last Updated
    February 4, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05240261
    Brief Title
    Sleep Disorders in Chronic Kidney Disease Patients
    Official Title
    Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESRAD on regular haemodialysis
    Arm Type
    Other
    Arm Description
    30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month.
    Arm Title
    CKD patients (predialydsis)
    Arm Type
    Other
    Arm Description
    30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month.
    Intervention Type
    Drug
    Intervention Name(s)
    Quetiapine
    Intervention Description
    Quetiapine 25 mg / day
    Primary Outcome Measure Information:
    Title
    1- change in Blood pressure measurement .
    Description
    follow up blood pressure ( millimeters of mercury (mm/hg)
    Time Frame
    3 months
    Title
    The Quality of Life Scale (QOLS)
    Description
    Scores can range from 16 to 112. higher scores indicate better life quality.
    Time Frame
    3 months
    Title
    Pittsburgh Sleep Quality Index score (PSQI S).
    Description
    Scale 0-21, higher scores indicate worse sleep quality.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    change in Estimated Glomerular filteration rate.
    Time Frame
    3 month
    Title
    proteinuria
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: Patients with history of psychosis. Patients with decompensated heart or liver disease. Patients with diabetes , autoimmune ,thyroid or neurological disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona Abdellatif Aly
    Phone
    00201065610527
    Email
    mona_abdellatif@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashraf Mohammed Elshazly
    Phone
    00201069176881

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25117823
    Citation
    Zhang J, Wang C, Gong W, Peng H, Tang Y, Li CC, Zhao W, Ye Z, Lou T. Association between sleep quality and cardiovascular damage in pre-dialysis patients with chronic kidney disease. BMC Nephrol. 2014 Aug 12;15:131. doi: 10.1186/1471-2369-15-131.
    Results Reference
    background
    PubMed Identifier
    29212081
    Citation
    Pengo MF, Ioratti D, Bisogni V, Ravarotto V, Rossi B, Bonfante L, Simioni F, Nalesso F, Maiolino G, Calo LA. In Patients with Chronic Kidney Disease Short Term Blood Pressure Variability is Associated with the Presence and Severity of Sleep Disorders. Kidney Blood Press Res. 2017;42(5):804-815. doi: 10.1159/000484357. Epub 2017 Nov 28.
    Results Reference
    background
    PubMed Identifier
    25276738
    Citation
    Parvan K, Lakdizaji S, Roshangar F, Mostofi M. Quality of sleep and its relationship to quality of life in hemodialysis patients. J Caring Sci. 2013 Nov 30;2(4):295-304. doi: 10.5681/jcs.2013.035. eCollection 2013 Dec.
    Results Reference
    background
    PubMed Identifier
    32418007
    Citation
    Hao Q, Xie M, Zhu L, Dou Y, Dai M, Wu Y, Tang X, Wang Q. Association of sleep duration with chronic kidney disease and proteinuria in adults: a systematic review and dose-response meta-analysis. Int Urol Nephrol. 2020 Jul;52(7):1305-1320. doi: 10.1007/s11255-020-02488-w. Epub 2020 May 16.
    Results Reference
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    Sleep Disorders in Chronic Kidney Disease Patients

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