Chronic Kidney DiseasesPhase 1NCT05240261
Sleep Disorders in Chronic Kidney Disease Patients
A Phase 1 study testing Quetiapine in people with Chronic Kidney Diseases, run by Assiut University.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with history of psychosis.
- Patients with decompensated heart or liver disease.
- Patients with diabetes , autoimmune ,thyroid or neurological disorders.
Trial locations and contacts
No sites are listed yet.
Ashraf Mohammed Elshazly contact
About this study
Official title: Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients
- 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 .
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Quetiapine
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Quetiapine 25 mg / day
| Study group | Role | What they receive |
|---|---|---|
| ESRAD on regular haemodialysis | Other | 30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month. Receives: Drug: Quetiapine |
| CKD patients (predialydsis) | Other | 30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month. Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- change in Blood pressure measurement .
follow up blood pressure ( millimeters of mercury (mm/hg)
Measured: 3 months
The Quality of Life Scale (QOLS)
Scores can range from 16 to 112. higher scores indicate better life quality.
Measured: 3 months
Pittsburgh Sleep Quality Index score (PSQI S).
Scale 0-21, higher scores indicate worse sleep quality.
Measured: 3 months
Secondary outcomes (2)
change in Estimated Glomerular filteration rate.
Measured: 3 month
proteinuria
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Abd Ellatif Aly Ismael, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240261
- Sponsor's protocol ID
- Chronic kidney disease (CKD)
- Status last verified
- Feb 2022
- First submitted
- 2 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25117823Pengo 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.
PubMed 29212081Parvan 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.
PubMed 25276738Hao 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.
PubMed 32418007
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05240261
- Acronym / sponsor ID
- Chronic kidney disease (CKD)
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRAD on regular haemodialysis | Other | Drug: Quetiapine30 ESRD Patients with sleep < 6 hours on regular haemodialysis . Before and after taking medications for 3 month. |
| CKD patients (predialydsis) | Other | Drug: Quetiapine30 CKD Patients (predialysis) with sleep < 6 hours . Before and after taking medications for 3 month. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with history of psychosis.
- Patients with decompensated heart or liver disease.
- Patients with diabetes , autoimmune ,thyroid or neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuetiapineQuetiapine 25 mg / day | Drug | CKD patients (predialydsis), ESRAD on regular haemodialysis |
Primary outcome
1- change in Blood pressure measurement .
Time frame: 3 months
follow up blood pressure ( millimeters of mercury (mm/hg)
The Quality of Life Scale (QOLS)
Time frame: 3 months
Scores can range from 16 to 112. higher scores indicate better life quality.
Pittsburgh Sleep Quality Index score (PSQI S).
Time frame: 3 months
Scale 0-21, higher scores indicate worse sleep quality.
2 secondary outcomes
change in Estimated Glomerular filteration rate.
Time frame: 3 month
proteinuria
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 25117823Zhang 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.
- Background: PubMed 29212081Pengo 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.
- Background: PubMed 25276738Parvan 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.
- Background: PubMed 32418007Hao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Mohammed Elshazly contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quetiapine in people with Chronic Kidney Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdellatif Aly (00201065610527, mona_abdellatif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- change in Blood pressure measurement . (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240261, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.