ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Recruiting

• Conditions: Temporomandibular Disorders (TMD); Sleep

• Registration Number: NCT06975709
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Detailed Description

Temporomandibular disorders (TMD) are complex conditions, which can have a significant impact on patients' health and quality of life. Furthermore, they are unclearly associated with sleep disorders. The aim of the study is to investigate the prevalence of TMD in patients with sleep disorders.

Study Timeline

• Study First Submitted: 2025-03-28
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18 years
• Famale and Male
• Signature of the privacy information form
• Signature of the informed consent form of the protocol
• Subjects capable of understanding and wanting
• Subjects suffering from a sleep disorder (Insomnia,Hypersomnia,Restless legs syndrome,REM sleep behavior disorder,Narcolepsy,Obstructive sleep apnea syndrome (OSAS),Primary snoring, REM parasomnias,Nocturnal epilepsy)

Exclusion Criteria

• Physical trauma to the head and neck area
• Painful oral pathologies (e.g. pulpitis, tooth fractures, tooth abscesses, tooth decay, canker sores and mucosal wounds)
• Recent dental treatments that may cause pain (e.g. tooth extraction, tooth root canal)
• Use of oral contraceptives
• Subjects not capable of understanding and wanting
• Patients suffering from neurological pathologies that may interfere with the completion of the questionnaires (ES dementia) or psychiatric pathologies or drug use as per DSM-5 criteria (including schizophrenia, bipolar, major depression, substance abuse, personality disorders).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	at enrollment	The main aim of the present study is to evaluate the prevalence of TMDs in patients with sleep disorders. This population was selected in order to contribute, in the context of scientific research, to the investigation into the association between temporomandibular disorders and sleep disorders, which include all those disorders that compromise both the quantity and quality of sleep with repercussions important on general health and quality of life, like: * Insomnia; * Hypersomnia; * Restless legs syndrome; * REM sleep behavior disorder; * Narcolepsy; * Obstructive sleep apnea syndrome (OSAS); * Primary snoring; * REM parasomnias (Sleepwalking, arousal disorders, excessive daytime sleepiness and night terrors); * Nocturnal epilepsy Patients with sleep disorders may be recruited in the observational study conducted by the University's Department of Dentistry Vita-Salute San Raffaele and the Neurology-sleep disorders unit of the San Raffaele Hospital in Turro, aimed at evaluating the prevalence of T

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	at enrollment	Through this study we also want to evaluate the difference between the prevalence of TMDs in patients with sleep disorders and the prevalence of TMDs in non-patological population through the data present in the scientific literature.

Trial Locations

Locations (2)

IRCCS Ospedale San Raffaele Turro; 🇮🇹 Milano, Italy

IRCCS San Raffaele Hospital; 🇮🇹 Milan, Italy