Sleep Disorders in Chronic Kidney Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

NCT00817427

Chronic Kidney Disease

COMPLETED NA

Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy

NCT00817674

Chronic Kidney Disease Sleep Loss

COMPLETED

Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois

NCT00817492

Chronic Kidney Disease

COMPLETED

Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments

NCT05371483

Narcolepsy Idiopathic Hypersomnia

ENROLLING_BY_INVITATION

Constitution of a Clinical, Neurophysiological and Biological Cohort for Chronic Sleep Disorders Responsible of Hypersomnolence

NCT03998020

Somnolence Disorder, Excessive

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESRAD on regular haemodialysis

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

Group Type OTHER

Quetiapine

Intervention Type DRUG

Quetiapine 25 mg / day

CKD patients (predialydsis)

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

Group Type OTHER

Quetiapine

Intervention Type DRUG

Quetiapine 25 mg / day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine

Quetiapine 25 mg / day

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes