ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

NCT06975709 | Recruiting

• 2 other identifiers: IRCCS San Raffaele HospitalCET 49-2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Conditions

Temporomandibular Disorders (TMD); Sleep

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  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

  at enrollment

Secondary Outcomes (1)

• Secondary Outcome

  at enrollment

Study Arms (1)

patients with TMD

Temporomandibular disorder (TMD), a common cause of chronic orofacial pain, is a group of painful and/or dysfunctional conditions of the masticatory muscles, temporomandibular joint (TMJ) and associated structures.

Other: Questionnaire and Physical Exam

Interventions

Questionnaire and Physical Exam OTHER

The diagnostic questionnaires will be administered and the participants' responses will subsequently be analyzed, evaluating the presence of temporomandibular disorders (DTMs) in patients with sleep disorders. The questionnaires will be administered to patients with a previous diagnosis of sleep disorder carried out at a specialist centre, consecutively belonging to the outpatient clinics of both centers U.O of Neurology-Sleep Disorders Center and U.O of Dentistry.

patients with TMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population must include Female and Male over 18 y.o with sleep disorders that meet inclusion and exclusion criteria.

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (2)

IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

NOT YET RECRUITING

IRCCS Ospedale San Raffaele Turro

Milan, Milano, 20127, Italy

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Simona Tecco, MD

CONTACT

+390226432970; tecco.simona@hsr.it

Luigi Ferini-Strambi, MD

CONTACT

+390226433363; ferinistrambi.luigi@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 16, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

IT (2)