NCT05153616

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

November 1, 2021

Enrollment Period

2.9 years

First QC Date

November 28, 2021

Last Update Submit

November 28, 2021

Conditions

The Aim of the Study Was to Screen Prevalence of Periodic Limb Movements Among Chronic Kidney Disease Patients

Outcome Measures

Primary Outcomes (1)

  • Periodic limb movement

    Screening the prevalence of periodic limb movement

    One night

Study Arms (1)

Diagnostic Polysomnography

EXPERIMENTAL
Diagnostic Test: Polysomnography

Interventions

PolysomnographyDIAGNOSTIC_TEST

Full night attended polysomnography to diagnose periodic limb movements

Diagnostic Polysomnography

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • chronic kidney disease

You may not qualify if:

  • diabetic, hepatic and chrest disease patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aswan University Hospital

Study Record Dates

First Submitted

November 28, 2021

First Posted

December 10, 2021

Study Start

May 1, 2017

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

December 10, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)