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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07292077
Enrollment
102
Registered
2025-12-18
Start date
2025-02-20
Completion date
2025-10-06
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome, Sleep Quality, Temporomandibular Joint Disorders

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

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.

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.

Interventions

None listed

Sponsors

Bozok University
CollaboratorOTHER
Gaziantep City Hospital
CollaboratorOTHER
Gulseren Demir Karakilic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
International Restless Legs Syndrome Study Group Diagnostic CriteriaAt baselineThis 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.
International Restless Legs Syndrome Study Group Severity Rating ScaleAt baselineThis 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.
Pittsburgh Sleep Quality IndexAt baselineThis 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.

Secondary

MeasureTime frameDescription
Mandibular Function Impairment QuestionnaireAt baselineThis questionnaire contains 17 items assessing the individual's perceived difficulty in performing mandibular movements and daily activities such as chewing, speaking, and yawning. Each item is scored on a five-point Likert scale ranging from 0 (no difficulty) to 4 (very severe difficulty). The total score ranges from 0 to 68, with higher scores indicating greater functional impairment of the mandible. The Turkish version of this questionnaire has demonstrated satisfactory validity and reliability
Hospital Anxiety and Depression ScaleAt baselineThis self-report instrument consists of 14 items designed to assess symptoms of anxiety and depression in adults. Seven items assess anxiety symptoms and seven items assess depressive symptoms. Each item is scored from 0 to 3, producing subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity. The Turkish version has been shown to be valid and reliable in clinical populations.
12-Item Short Form Health SurveyAt baselineThis health-related quality of life questionnaire includes 12 items that assess physical and mental well-being. The instrument provides summary scores reflecting physical and mental health status, with higher scores indicating better perceived health and functioning. The Turkish version has demonstrated adequate psychometric properties for use in population-based and clinical studies

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026