NCT07292077

Restless Legs Syndrome in Temporomandibular Joint Disorders

Frequency of Restless Legs Syndrome in Patients With Temporomandibular Joint Disorders and Its Effect on Sleep Quality

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Gulseren Demir Karakilic · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The temporomandibular joint is a complex musculoskeletal structure, and temporomandibular joint dysfunction is a clinical condition involving the joint, the masticatory muscles, and surrounding tissues. Restless legs syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an uncontrollable urge to move, particularly during periods of rest or at night. Previous studies have suggested possible associations between temporomandibular joint dysfunction, bruxism, sleep disturbances, and restless legs syndrome. However, the prevalence of restless legs syndrome and its impact on sleep quality in patients with temporomandibular joint dysfunction remain insufficiently investigated. This study is designed as an observational, cross-sectional, descriptive investigation. It will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital and Gaziantep Dr. Ersin Arslan Training and Research Hospital. The study population will consist of adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction, are cognitively intact, literate, and voluntarily agree to participate. The control group will include healthy volunteers without a diagnosis of temporomandibular joint dysfunction, matched to the patient group for age and sex. Control participants will also be cognitively intact, literate, and willing to provide written informed consent. Data Collection Tools (Final Version) Sociodemographic Questionnaire This 25-item form records age, sex, marital status, educational level, income status, comorbidities, disease duration, and other relevant clinical characteristics. Mandibular Functional Impairment Questionnaire This is a 17-item questionnaire scored on a five-point Likert scale, yielding total scores ranging from 0 to 68. Higher scores indicate greater functional impairment of the mandible. The instrument evaluates patient-perceived difficulty in performing mandibular movements and daily functional tasks. Hospital Anxiety and Depression Scale This 14-item self-report questionnaire includes two subscales assessing anxiety and depression symptoms. Each item is scored from 0 to 3. Subscale scores range from 0 to 21, with higher scores indicating greater symptom severity. International Restless Legs Syndrome Study Group Diagnostic Criteria These clinical diagnostic criteria focus on the core symptoms of restless legs syndrome. Diagnosis is based on patient history and the presence of all essential diagnostic features. International Restless Legs Syndrome Severity Scale This 10-item rating scale evaluates symptom severity, frequency, and impact on daily life and mood. Each item is scored from 0 to 4, producing a total score between 0 and 40. Higher scores indicate greater symptom severity. Pittsburgh Sleep Quality Index This 24-item questionnaire assesses sleep quality over the previous month across seven components, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. Short Form 12 Health Survey This 12-item questionnaire evaluates health-related quality of life across physical and mental health domains, including physical functioning, role limitations, bodily pain, general health perception, vitality, social functioning, emotional role limitations, and mental health.

Conditions

• Temporomandibular Joint Disorders
• Restless Legs Syndrome
• Sleep Quality

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-06-30
• Completion: 2025-10-06
• First posted: 2025-12-18
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)