Restless Legs SyndromeFLAT-RLSNCT07117591
Restless Legs Syndrome and Sleep Quality in Pes Planus
An observational study of Restless Legs Syndrome and Sleep Quality, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Pes planus, also known as flatfoot, is a common foot deformity that can affect the biomechanics of the lower limbs. However, its relationship with neurological conditions has not been studied extensively. 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, Sleep Quality, Pain
- How many people
- 242 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jul 2025
- 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: This study includes adult patients aged 18-65 with clinically diagnosed pes planus and age- and sex-matched healthy controls without foot deformity or leg pain. Participants were recruited from three tertiary hospitals in Turkey and evaluated for Restless Legs Syndrome, pain, emotional status, sleep quality, and quality of life.
Who may be able to join
- Age between 18 and 65 years
- Clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist (for patient group)
- Ability to understand and provide written informed consent
- For control group: healthy individuals matched by age and sex without pes planus or leg pain
Who cannot join
- History of diabetes mellitus, hypothyroidism, chronic renal failure, neuropathic disorders, vasculitis, lumbar disc disease
- Previous foot fracture or surgery
- Rheumatologic diseases affecting pain perception (e.g., rheumatoid arthritis, ankylosing spondylitis, fibromyalgia)
- Significant circulatory disorders in lower extremities
- Undergoing chemotherapy or radiotherapy
- Cognitive impairment preventing questionnaire completion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100
About this study
Official title: Frequency of Restless Legs Syndrome and Its Impact on Sleep Quality in Patients With Pes Planus: A Multicenter Observational Study
Pes planus, also known as flatfoot, is a common foot deformity that can affect the biomechanics of the lower limbs. However, its relationship with neurological conditions has not been studied extensively. Restless Legs Syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an urge to move them, especially during periods of rest, which can negatively affect sleep quality.
The aim of this multicenter cross-sectional study, conducted at Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital, is to determine the frequency of Restless Legs Syndrome in patients diagnosed with pes planus and to examine its effects on pain, emotional status, sleep quality, and quality of life. The study included 122 patients aged between 18 and 65 years with clinically diagnosed pes planus, and 120 healthy individuals matched for age and sex. Participants were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale for Restless Legs Syndrome, the Visual Analog Scale and Foot Function Index for pain and foot function, the Hospital Anxiety and Depression Scale for emotional status, the Pittsburgh Sleep Quality Index for sleep quality, and the Short Form-36 Health Survey for quality of life.
Read the detailed description
Pes planus, commonly known as flatfoot, is a frequent foot deformity characterized by a lowered medial longitudinal arch, which can affect lower limb biomechanics and overall posture. While its mechanical effects on the musculoskeletal system have been widely studied, the potential neurological and psychosocial implications of pes planus remain insufficiently explored.
Restless Legs Syndrome (RLS) is a neurological disorder marked by an uncontrollable urge to move the legs, often accompanied by unpleasant sensations. Symptoms typically worsen during rest or inactivity and can lead to significant sleep disturbances and reduced quality of life.
This multicenter cross-sectional observational study was designed to investigate the prevalence of RLS among patients clinically diagnosed with pes planus, and to evaluate the impact of RLS on pain severity, emotional well-being, sleep quality, and overall health-related quality of life.
The study was conducted between December 2024 and July 2025 at three tertiary care centers: Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital. A total of 242 participants were recruited, including 122 patients with clinically confirmed pes planus and 120 age- and sex-matched healthy controls without foot deformities or leg pain.
Inclusion criteria for patients were age between 18 and 65 years and a clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist, based on physical examination. Exclusion criteria included the presence of systemic diseases such as diabetes mellitus, hypothyroidism, chronic renal failure, neuropathies, rheumatological conditions, history of foot surgery or fractures, and other conditions potentially affecting pain perception or neurological status.
Data collection included demographic information (age, sex, body mass index, educational status, smoking and alcohol use) and clinical variables (duration and severity of leg pain). The presence and severity of RLS were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale, which are internationally recognized tools for diagnosis and quantification of symptom severity.
Pain intensity and foot function were measured using the Visual Analog Scale and the Foot Function Index, respectively. Emotional status was evaluated by the Hospital Anxiety and Depression Scale. Sleep quality was assessed with the Pittsburgh Sleep Quality Index, and overall quality of life was measured by the Short Form-36 Health Survey.
All assessments were performed by trained evaluators following a standardized protocol to ensure consistency across study sites. Data were collected through patient interviews, questionnaires, and clinical examinations.
The primary objective was to determine the frequency of Restless Legs Syndrome among pes planus patients compared to healthy controls. Secondary objectives included evaluating the relationship between RLS severity and pain intensity, emotional status, sleep quality, and quality of life.
This study aims to shed light on the complex interaction between biomechanical foot deformities and neurological symptoms, with the goal of informing comprehensive, multidisciplinary treatment approaches for patients with pes planus.
- Conditions
- Restless Legs Syndrome, Sleep Quality, Pain, Quality of Life, Pes Planus, Depression
- Keywords
- Pes Planus, Restless Legs Syndrome, Sleep Disturbance, Foot Pain, Anxiety, Depression, Quality of Life, Foot Function
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders, Pain, Flatfoot, Depression, Parasomnias, Anxiety Disorders
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 |
|---|---|---|
| Patient group | Participants in this group were clinically diagnosed with pes planus (flatfoot) by a physical medicine and rehabilitation specialist, based on physical examination findings. Individuals were aged between 18 and 65 years and presented with lower extremity pain. No intervention was applied. This group was evaluated using standardized questionnaires to assess the presence and severity of Restless Legs Syndrome, pain levels, emotional status, sleep quality, and quality of life. | |
| the Control group | This group included healthy volunteers between the ages of 18 and 65 who had no clinical signs of pes planus or lower extremity pain. Participants were matched to the patient group by age and sex. No medical or rehabilitative intervention was applied. They were evaluated using the same standardized tools to assess the presence of Restless Legs Syndrome, emotional status, sleep quality, and quality of life, for comparison with the patient group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Restless Legs Syndrome Study Group Diagnostic Criteria
Restless Legs Syndrome will be diagnosed using the International Restless Legs Syndrome Study Group Diagnostic Criteria, which consist of five essential clinical criteria. All criteria must be met for diagnosis. These include: (1) an urge to move the legs; (2) symptoms that begin or worsen during rest or inactivity; (3) symptoms relieved by movement; (4) symptoms worse in the evening or at night; and (5) symptoms not solely accounted for by another medical or behavioral condition.This tool, originally developed in 1995 and revised in 2014, includes five essential diagnostic criteria and is based solely on clinical history. All criteria must be met for a diagnosis of restless legs syndrome
Measured: At baseline
The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale
The severity of Restless Legs Syndrome symptoms will be assessed using the International Restless Legs Syndrome Study Group Severity Rating Scale. This is a validated 10-item questionnaire that evaluates symptom intensity, frequency, sleep disruption, and the psychosocial impact of Restless Legs Syndrome. Each item is scored from 0 to 4, with total scores ranging from 0 to 40. Severity is categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The scale has been validated for use in Turkish populations.Total severity score (range 0-40) and severity category distribution (mild/moderate/severe/very severe).
Measured: At baseline
The Pittsburg Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a 24-item self-reported questionnaire that evaluates sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A total score of 5 or above is used to define poor sleep quality. The index has been validated in Turkish populations.Total Pittsburgh Sleep Quality Index score and proportion of participants classified as poor sleepers (score ≥5)
Measured: At baseline
Secondary outcomes (3)
The Foot Function Index
Foot function will be evaluated using the Foot Function Index, a 23-item questionnaire assessing three subdomains: pain, disability, and activity limitation. Each item is scored on a scale to quantify the impact of foot problems on daily activities. The total score reflects overall foot function impairment, with higher scores indicating greater dysfunction. The Turkish version of this scale has been validated for reliability and validity.Total Foot Function Index score and scores of subdomains (pain, disability, activity limitation)
Measured: At baseline
The Hospital Anxiety and Depression Scale
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale, a 14-item self-report questionnaire consisting of two subscales: anxiety and depression. Each subscale includes 7 items scored to evaluate symptom severity. Scores of 8 or above on each subscale indicate clinically significant anxiety or depression. The scale has been validated in Turkish populations. Subscale scores for anxiety and depression; number and percentage of participants scoring 8 or above on each subscale
Measured: At baseline
SF-36
Quality of life will be measured using the Short Form-36 (SF-36) Health Survey, a 36-item self-administered questionnaire assessing eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health. Each subscale is scored from 0 to 100, with higher scores indicating better perceived health status. The Turkish version of the SF-36 has been validated and is widely used in clinical research. Scores on each of the eight SF-36 subscales and composite physical and mental health scores
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Dec 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Cross-sectional
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Responsible party
- Principal investigator, Gulseren Demir Karakilic, Bozok University
- Investigators
- Gülseren Demir Karakılıç, Asst Prof, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117591
- Sponsor's protocol ID
- 2024/21
- Acronym
- FLAT-RLS
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) from this study, including de-identified demographic, clinical, and questionnaire data, will be available upon reasonable request after publication of the study results. Requests should be submitted to the corresponding author, who will evaluate the request for ethical and privacy compliance before sharing
Publications
Kocyigit H (1999) Turkish validity and reliability of short-form 36. Drug Treat 12:102-106
Ağargün MY (1996) Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi 7:107
Aydemir O, Güvenir T, Küey L, Kültür S (1997) Reliability and validity of the Turkish version of hospital anxiety and depression scale. Turkish journal of psychiatry 8:280-287
Ay E (2017) Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. In. Sağlık Bilimleri Enstitüsü.
Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
PubMed 25023924YALIMAN A, ŞEN Eİ, ESKİYURT N, BUDIMAN-MAK E (2014) Ayak Fonksiyon İndeksi'nin Plantar Fasiitli Hastalarda Türkçe'ye Çeviri ve Adaptasyonu. Turkish Jour
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Restless Legs Syndrome and Its Impact on Sleep Quality in Patients With Pes Planus: A Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07117591
- Acronym / sponsor ID
- FLAT-RLS / 2024/21
- Conditions
- Restless Legs Syndrome, Sleep Quality, Pain, Quality of Life, Pes Planus, Depression
- Keywords
- Pes Planus, Restless Legs Syndrome, Sleep Disturbance, Foot Pain, Anxiety, Depression, Quality of Life, Foot Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Aug 2025 (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.
Pes planus, also known as flatfoot, is a common foot deformity that can affect the biomechanics of the lower limbs. However, its relationship with neurological conditions has not been studied extensively. Restless Legs Syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an urge to move them, especially during periods of rest, which can negatively affect sleep quality.
The aim of this multicenter cross-sectional study, conducted at Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital, is to determine the frequency of Restless Legs Syndrome in patients diagnosed with pes planus and to examine its effects on pain, emotional status, sleep quality, and quality of life. The study included 122 patients aged between 18 and 65 years with clinically diagnosed pes planus, and 120 healthy individuals matched for age and sex. Participants were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale for Restless Legs Syndrome, the Visual Analog Scale and Foot Function Index for pain and foot function, the Hospital Anxiety and Depression Scale for emotional status, the Pittsburgh Sleep Quality Index for sleep quality, and the Short Form-36 Health Survey for quality of life.
Detailed description
Pes planus, commonly known as flatfoot, is a frequent foot deformity characterized by a lowered medial longitudinal arch, which can affect lower limb biomechanics and overall posture. While its mechanical effects on the musculoskeletal system have been widely studied, the potential neurological and psychosocial implications of pes planus remain insufficiently explored.
Restless Legs Syndrome (RLS) is a neurological disorder marked by an uncontrollable urge to move the legs, often accompanied by unpleasant sensations. Symptoms typically worsen during rest or inactivity and can lead to significant sleep disturbances and reduced quality of life.
This multicenter cross-sectional observational study was designed to investigate the prevalence of RLS among patients clinically diagnosed with pes planus, and to evaluate the impact of RLS on pain severity, emotional well-being, sleep quality, and overall health-related quality of life.
The study was conducted between December 2024 and July 2025 at three tertiary care centers: Etlik Zübeyde Hanım Women's Health Training and Research Hospital, Etlik City Hospital in Ankara, and Yozgat City Hospital. A total of 242 participants were recruited, including 122 patients with clinically confirmed pes planus and 120 age- and sex-matched healthy controls without foot deformities or leg pain.
Inclusion criteria for patients were age between 18 and 65 years and a clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist, based on physical examination. Exclusion criteria included the presence of systemic diseases such as diabetes mellitus, hypothyroidism, chronic renal failure, neuropathies, rheumatological conditions, history of foot surgery or fractures, and other conditions potentially affecting pain perception or neurological status.
Data collection included demographic information (age, sex, body mass index, educational status, smoking and alcohol use) and clinical variables (duration and severity of leg pain). The presence and severity of RLS were assessed using the International Restless Legs Syndrome Study Group Diagnostic Criteria and Severity Rating Scale, which are internationally recognized tools for diagnosis and quantification of symptom severity.
Pain intensity and foot function were measured using the Visual Analog Scale and the Foot Function Index, respectively. Emotional status was evaluated by the Hospital Anxiety and Depression Scale. Sleep quality was assessed with the Pittsburgh Sleep Quality Index, and overall quality of life was measured by the Short Form-36 Health Survey.
All assessments were performed by trained evaluators following a standardized protocol to ensure consistency across study sites. Data were collected through patient interviews, questionnaires, and clinical examinations.
The primary objective was to determine the frequency of Restless Legs Syndrome among pes planus patients compared to healthy controls. Secondary objectives included evaluating the relationship between RLS severity and pain intensity, emotional status, sleep quality, and quality of life.
This study aims to shed light on the complex interaction between biomechanical foot deformities and neurological symptoms, with the goal of informing comprehensive, multidisciplinary treatment approaches for patients with pes planus.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Participants in this group were clinically diagnosed with pes planus (flatfoot) by a physical medicine and rehabilitation specialist, based on physical examination findings. Individuals were aged between 18 and 65 years and presented with lower extremity pain. No intervention was applied. This group was evaluated using standardized questionnaires to assess the presence and severity of Restless Legs Syndrome, pain levels, emotional status, sleep quality, and quality of life. |
| the Control group | – | –This group included healthy volunteers between the ages of 18 and 65 who had no clinical signs of pes planus or lower extremity pain. Participants were matched to the patient group by age and sex. No medical or rehabilitative intervention was applied. They were evaluated using the same standardized tools to assess the presence of Restless Legs Syndrome, emotional status, sleep quality, and quality of life, for comparison with the patient group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients aged 18-65 with clinically diagnosed pes planus and age- and sex-matched healthy controls without foot deformity or leg pain. Participants were recruited from three tertiary hospitals in Turkey and evaluated for Restless Legs Syndrome, pain, emotional status, sleep quality, and quality of life.
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Clinical diagnosis of pes planus by a physical medicine and rehabilitation specialist (for patient group)
- Ability to understand and provide written informed consent
- For control group: healthy individuals matched by age and sex without pes planus or leg pain
Key exclusion criteria (6 listed)
- History of diabetes mellitus, hypothyroidism, chronic renal failure, neuropathic disorders, vasculitis, lumbar disc disease
- Previous foot fracture or surgery
- Rheumatologic diseases affecting pain perception (e.g., rheumatoid arthritis, ankylosing spondylitis, fibromyalgia)
- Significant circulatory disorders in lower extremities
- Undergoing chemotherapy or radiotherapy
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
The International Restless Legs Syndrome Study Group Diagnostic Criteria
Time frame: At baseline
Restless Legs Syndrome will be diagnosed using the International Restless Legs Syndrome Study Group Diagnostic Criteria, which consist of five essential clinical criteria. All criteria must be met for diagnosis. These include: (1) an urge to move the legs; (2) symptoms that begin or worsen during rest or inactivity; (3) symptoms relieved by movement; (4) symptoms worse in the evening or at night; and (5) symptoms not solely accounted for by another medical or behavioral condition.This tool, originally developed in 1995 and revised in 2014, includes five essential diagnostic criteria and is based solely on clinical history. All criteria must be met for a diagnosis of restless legs syndrome
The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale
Time frame: At baseline
The severity of Restless Legs Syndrome symptoms will be assessed using the International Restless Legs Syndrome Study Group Severity Rating Scale. This is a validated 10-item questionnaire that evaluates symptom intensity, frequency, sleep disruption, and the psychosocial impact of Restless Legs Syndrome. Each item is scored from 0 to 4, with total scores ranging from 0 to 40. Severity is categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The scale has been validated for use in Turkish populations.Total severity score (range 0-40) and severity category distribution (mild/moderate/severe/very severe).
The Pittsburg Sleep Quality Index
Time frame: At baseline
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a 24-item self-reported questionnaire that evaluates sleep quality and disturbances over the past month. Scores range from 0 to 21, with higher scores indicating poorer sleep quality. A total score of 5 or above is used to define poor sleep quality. The index has been validated in Turkish populations.Total Pittsburgh Sleep Quality Index score and proportion of participants classified as poor sleepers (score ≥5)
3 secondary outcomes
The Foot Function Index
Time frame: At baseline
The Hospital Anxiety and Depression Scale
Time frame: At baseline
SF-36
Time frame: At baseline
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 17 Aug 2025.
- BackgroundKocyigit H (1999) Turkish validity and reliability of short-form 36. Drug Treat 12:102-106
- BackgroundAğargün MY (1996) Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi 7:107
- BackgroundAydemir O, Güvenir T, Küey L, Kültür S (1997) Reliability and validity of the Turkish version of hospital anxiety and depression scale. Turkish journal of psychiatry 8:280-287
- BackgroundAy E (2017) Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. In. Sağlık Bilimleri Enstitüsü.
- Background: PubMed 25023924Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- BackgroundYALIMAN A, ŞEN Eİ, ESKİYURT N, BUDIMAN-MAK E (2014) Ayak Fonksiyon İndeksi'nin Plantar Fasiitli Hastalarda Türkçe'ye Çeviri ve Adaptasyonu. Turkish Jour
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) from this study, including de-identified demographic, clinical, and questionnaire data, will be available upon reasonable request after publication of the study results. Requests should be submitted to the corresponding author, who will evaluate the request for ethical and privacy compliance before sharing
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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.
Gülseren Demir Karakılıç, Asst Prof principal investigator
Yozgat Bozok University
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 and Sleep Quality, run by Bozok University 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 4 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 17 Aug 2025. 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?
The International Restless Legs Syndrome Study Group Diagnostic Criteria (time frame: At baseline). 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 NCT07117591, which also lists 6 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 17 Aug 2025.