The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease PatientsNCT05153616
Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
A study testing Polysomnography in people with The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients
- What is being tested?
- Polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 10 Mar 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- chronic kidney disease
Who cannot join
- diabetic, hepatic and chrest disease patients
Trial locations and contacts
1 site in 1 country.
About this study
Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. It may be accompanied by frequent nocturnal arousals, and if so, this sleep disturbance may cause excessive daytime sleepiness. Chronic kidney disease patients are at risk of periodic leg movements and common causes are iron deficiency, anemia, raised serum calcium and central and peripheral nervous system disorders.
- Being tested
- Polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Full night attended polysomnography to diagnose periodic limb movements
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Polysomnography | Experimental | Not described Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodic limb movement
Screening the prevalence of periodic limb movement
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 May 2017
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease PatientsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Kotb Mohamed, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153616
- Sponsor's protocol ID
- 150/7/17
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodic Limb Movements Among Dialysis and Non-dialysis Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05153616
- Acronym / sponsor ID
- 150/7/17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 10 Dec 2021 (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.
Periodic leg movement disorder is defined as periodic episodes of repetitive limb movements during sleep that mainly occur in the lower limb, including the hips, knees and toes and sometimes affects the upper limb. It may be accompanied by frequent nocturnal arousals, and if so, this sleep disturbance may cause excessive daytime sleepiness. Chronic kidney disease patients are at risk of periodic leg movements and common causes are iron deficiency, anemia, raised serum calcium and central and peripheral nervous system disorders.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Polysomnography | Experimental | Diagnostic Test: Polysomnography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chronic kidney disease
Key exclusion criteria (1 listed)
- diabetic, hepatic and chrest disease patients
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 |
|---|---|---|
| PolysomnographyFull night attended polysomnography to diagnose periodic limb movements | Diagnostic test | Diagnostic Polysomnography |
Primary outcome
Periodic limb movement
Time frame: One night
Screening the prevalence of periodic limb movement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography in people with The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients, run by Aswan University Hospital at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodic limb movement (time frame: One night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.