Restless Legs Syndrome in Temporomandibular Joint Disorders

NCT07292077 | Completed

• 1 other identifier: 140/2025
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. The study will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. Adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction and meet the inclusion criteria will be invited to participate. An age- and sex-matched control group consisting of individuals without temporomandibular joint dysfunction will also be recruited. All participants will undergo face-to-face structured interviews during which standardized and validated questionnaires will be administered. The study will collect sociodemographic data, clinical characteristics, and responses to validated assessment tools measuring mandibular function, anxiety and depression symptoms, restless legs syndrome, sleep quality, and health-related quality of life.

Conditions

Temporomandibular Joint Disorders; Restless Legs Syndrome; Sleep Quality

Keywords

Temporomandibular Disorder; Restless Legs Syndrome; Sleep Quality; Mandibular Function; Quality of Life; The International Restless Legs Syndrome Study Group Diagnostic Criteria; The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale; the Pittsburgh Sleep Quality Index; SF-12; Cross-sectional Study

Outcome Measures

Primary Outcomes (3)

• International Restless Legs Syndrome Study Group Diagnostic Criteria

  This diagnostic framework defines the presence of restless legs syndrome based on standardized clinical features, including an urge to move the legs, worsening of symptoms during rest, partial or complete relief with movement, and worsening of symptoms in the evening or at night. These diagnostic criteria have been adapted for use in Turkish-speaking populations and are used to determine whether participants meet the clinical diagnosis of restless legs syndrome.

  At baseline

• International Restless Legs Syndrome Study Group Severity Rating Scale

  This scale consists of 10 questions assessing the severity, frequency, and impact of restless legs syndrome symptoms on daily life. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom severity. Severity categories are defined as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The Turkish version of this scale has demonstrated acceptable reliability and validity for clinical and research use.

  At baseline

• Pittsburgh Sleep Quality Index

  This questionnaire evaluates sleep quality over the previous month. It includes 24 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score greater than 5 reflects poor sleep quality. The Turkish version has been shown to be valid and reliable in adult populations.

  At baseline

Secondary Outcomes (3)

• Mandibular Function Impairment Questionnaire

  At baseline

• Hospital Anxiety and Depression Scale

  At baseline

• 12-Item Short Form Health Survey

  At baseline

Study Arms (2)

Temporomandibular Disorder Group

This group includes adults aged 18 to 65 years who were clinically diagnosed with temporomandibular joint disorder at the otorhinolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. All participants were cognitively competent, literate, and provided written informed consent. Participants completed standardized questionnaires assessing mandibular function, symptoms of anxiety and depression, severity of restless legs syndrome, sleep quality, and health-related quality of life.

Healthy Control Group

This group includes healthy adults without a diagnosis of temporomandibular joint disorder who were matched to the patient group for age and sex. All participants were cognitively competent, literate, and provided written informed consent. Control participants completed the same standardized questionnaires as the patient group to allow comparison of sleep quality, emotional status, and health-related quality of life between groups.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included adults aged 18 to 65 years who were recruited from the otorhinolaryngology outpatient clinic of Gaziantep City Hospital. The patient group consisted of individuals with a clinical diagnosis of temporomandibular joint disorder, while the control group comprised healthy volunteers without temporomandibular joint disorder who were matched to the patient group for age and sex.

You may qualify if:

• Adults aged 18 to 65 years
• For the patient group: clinical diagnosis of temporomandibular joint disorder
• Cognitively intact and able to understand study procedures
• Literate and able to complete self-report questionnaires
• Willing to participate and provided written informed consent

You may not qualify if:

• Presence of neurological or psychiatric disorders
• Cognitive impairment that interferes with questionnaire completion
• Systemic diseases that may affect sleep or motor function
• Current use of medications that may influence sleep or motor function
• Refusal or inability to provide informed consent

Sponsors & Collaborators

• Gulseren Demir Karakilic: lead
• Bozok University: collaborator
• Gaziantep City Hospital: collaborator

Study Sites (1)

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (6)

• Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.

  PMID: 35730511 BACKGROUND

• Ağargün, M.Y., Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 1996. 7: p. 107.

  BACKGROUND

• Ay, E., Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. 2017, Sağlık Bilimleri Enstitüsü.

  BACKGROUND

• 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.

  PMID: 25023924 BACKGROUND

• Aydemir, Ö., et al., Validity and reliability of Turkish version of hospital anxiety and depression scale. Turk Psikiyatri Derg, 1997. 8(4): p. 280-7

  BACKGROUND

• Kılınç, H.E., et al., Further Validity and Reliability of Turkish Version of the Mandibular Functional Impairment Questionnaire in Patients with Temporomandibular Dysfunction. Journal of Basic and Clinical Health Sciences, 2022. 7(1): p. 214-222.

  BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Restless Legs Syndrome; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: February 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 6, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The individual participant data and supporting documents will be available starting six months after publication of the study results and will remain accessible for a period of five years following publication.
• Access Criteria: Access to the de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a reasonable and scientifically valid request to the corresponding author. Requests will be reviewed by the study investigators, and access will be provided for research purposes only. Data will be shared in a secure manner through institutional data transfer or encrypted electronic communication.

Locations

TU (1)