Restless Legs SyndromeNCT04906486
Autonomic Assessment in Patients With Restless Legs Syndrome
An observational study of Restless Legs Syndrome, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2020to 12 Apr 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients were selected from a tertiary care neurology outpatient clinic. Age and gender matched control group obtained from the family members of the tertiary care hospital's staff.
Who may be able to join
- For the patient group:
- age >18, <65
- newly diagnosed, drug naive patients with primary restless legs syndrome
- For the control group:
- age >18, <65
- participants without chronic systemic disorder
Who cannot join
- previous diagnosis of primary RLS
- subjects with secondary RLS
- concomitant use of drugs that could interfere with autonomic nervous system
- individuals with a known acute/chronic medical disease
- individuals with a minimental test score < 25/30
- sleep disorders that could affect test performances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital
Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. The objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with RLS.
Read the detailed description
Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state.
Although, the clinical importance of autonomic involvement in patients with restless legs syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction.
Previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction in patients with RLS. Despite many studies about electrophysiological autonomic changes in RLS, number of studies exploring autonomic functions by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.
In this study, the investigators plan to compare the presence of autonomic symptoms by using Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive RLS patients to healthy controls. In addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with RLS.
- Conditions
- Restless Legs Syndrome
- Keywords
- restless legs syndrome, autonomic dysfunction, dysautonomia, SCOPA-AUT questionnaire
- Medical subject headings
- Restless Legs Syndrome, Primary Dysautonomias, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational: Patients with restless legs syndrome | A total of 70 patients who diagnosed with primary restless legs syndrome according to the five essential criteria as established by the International Restless Legs Syndrome Study Group. | |
| Observational: Healthy controls | The control group consisted of 85 age- and gender-matched healthy volunteers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)
Presence and severity of autonomic dysfunction noted by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire [SCOPA-AUT, including six domains (gastrointestinal,urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual) with 25-items and a 4 -point Likert-type scale ranging from 0 to 69] in patients with restless legs syndrome vs. healthy controls.
Measured: 6 months
Age (years)
Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.
Measured: 6 months
Age of disease onset (years)
Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.
Measured: 6 months
Disease duration (years)
Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.
Measured: 6 months
Disease severity (as measured by International Restless Legs Scale) (points)
Correlation between autonomic dysfunction and disease severity (as measured by International Restless Legs Scale,5-point Likert-type scale ranging from 0 to 40; mild= 0-10; moderate= 11-20; severe= 21-30; very severe= 31-40) in patients with restless legs syndrome noted.
Measured: 6 months
Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)
Correlation between autonomic dysfunction and excessive daytime sleepiness [as measured by Epworth Sleepiness scale ,8-items with a 4-point Likert-type scale ( 0=would never doze,1=slight chance,2=moderate chance, 3= high chance) ranging from 0 to 24 points] in patients with restless legs syndrome noted.
Measured: 6 months
Body mass index (kg/m2)
Correlation between autonomic dysfunction and body mass index (kg/m2, as calculated by dividing weight in kilograms by their height in metres squared) in patients with restless legs syndrome noted.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start12 Nov 2020
- Primary completion10 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sehnaz Basaran, Kocaeli Derince Education and Research Hospital
- Investigators
- SEHNAZ BASARAN, MD, Principal investigator, KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906486
- Sponsor's protocol ID
- 2011-KAEK-27/2020-E.2000173683
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet
Publications
Basaran S, Akinci E. Screening autonomic functions in patients with restless legs syndrome: A case-control study in a tertiary care hospital. Auton Neurosci. 2022 Jan;237:102924. doi: 10.1016/j.autneu.2021.102924. Epub 2021 Nov 29.
PubMed 34871924
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT04906486
- Acronym / sponsor ID
- 2011-KAEK-27/2020-E.2000173683
- Conditions
- Restless Legs Syndrome
- Keywords
- restless legs syndrome, autonomic dysfunction, dysautonomia, SCOPA-AUT questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 28 May 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.
Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. The objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with RLS.
Detailed description
Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state.
Although, the clinical importance of autonomic involvement in patients with restless legs syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction.
Previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction in patients with RLS. Despite many studies about electrophysiological autonomic changes in RLS, number of studies exploring autonomic functions by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.
In this study, the investigators plan to compare the presence of autonomic symptoms by using Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive RLS patients to healthy controls. In addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with RLS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational: Patients with restless legs syndrome | – | –A total of 70 patients who diagnosed with primary restless legs syndrome according to the five essential criteria as established by the International Restless Legs Syndrome Study Group. |
| Observational: Healthy controls | – | –The control group consisted of 85 age- and gender-matched healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were selected from a tertiary care neurology outpatient clinic. Age and gender matched control group obtained from the family members of the tertiary care hospital's staff.
Key inclusion criteria (6 listed)
- age >18, <65
- newly diagnosed, drug naive patients with primary restless legs syndrome
- age >18, <65
- participants without chronic systemic disorder
Key exclusion criteria (6 listed)
- previous diagnosis of primary RLS
- subjects with secondary RLS
- concomitant use of drugs that could interfere with autonomic nervous system
- individuals with a known acute/chronic medical disease
- individuals with a minimental test score < 25/30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)
Time frame: 6 months
Presence and severity of autonomic dysfunction noted by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire [SCOPA-AUT, including six domains (gastrointestinal,urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual) with 25-items and a 4 -point Likert-type scale ranging from 0 to 69] in patients with restless legs syndrome vs. healthy controls.
Age (years)
Time frame: 6 months
Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.
Age of disease onset (years)
Time frame: 6 months
Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.
Disease duration (years)
Time frame: 6 months
Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.
Disease severity (as measured by International Restless Legs Scale) (points)
Time frame: 6 months
Correlation between autonomic dysfunction and disease severity (as measured by International Restless Legs Scale,5-point Likert-type scale ranging from 0 to 40; mild= 0-10; moderate= 11-20; severe= 21-30; very severe= 31-40) in patients with restless legs syndrome noted.
Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)
Time frame: 6 months
Correlation between autonomic dysfunction and excessive daytime sleepiness [as measured by Epworth Sleepiness scale ,8-items with a 4-point Likert-type scale ( 0=would never doze,1=slight chance,2=moderate chance, 3= high chance) ranging from 0 to 24 points] in patients with restless legs syndrome noted.
Body mass index (kg/m2)
Time frame: 6 months
Correlation between autonomic dysfunction and body mass index (kg/m2, as calculated by dividing weight in kilograms by their height in metres squared) in patients with restless legs syndrome noted.
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 28 May 2021.
- Derived from this study: PubMed 34871924Basaran S, Akinci E. Screening autonomic functions in patients with restless legs syndrome: A case-control study in a tertiary care hospital. Auton Neurosci. 2022 Jan;237:102924. doi: 10.1016/j.autneu.2021.102924. Epub 2021 Nov 29.
- Individual participant dataSharing planned: Undecided. not decided yet
Related trials for Restless Legs Syndrome
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Neuromodulation to Overcome Severe Restless Legs Syndrome
Restless Leg Syndrome (RLS), Spinal Cord Stimulation (SCS)
Not yet recruitingPhase 2
Tolerability and Efficacy of CBD Extract for RLS Treatment
Restless Leg Syndrome
Recruiting
Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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.
SEHNAZ BASARAN, MD principal investigator
KOCAELİ DERİNCE EDUCATION AND RESEARCH HOSPİTAL DEPARTMENT OF NEUROLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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 28 May 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 Turkey (Türkiye). 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?
Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points) (time frame: 6 months). The study lists 7 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 NCT04906486, which also lists 1 linked publication.
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 28 May 2021.