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Recruiting NCT06975709

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Observational Temporomandibular Disorders (TMD) Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire and Physical Exam.
Who it may be relevant to
Registry conditions: Temporomandibular Disorders (TMD), Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Questionnaire and Physical Exam
    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.

Primary outcome measures

  • Primary Outcome [Time frame: at enrollment]
Secondary outcome measures (1)
  • Secondary Outcome [Time frame: at enrollment]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • IRCCS San Raffaele Hospital — Milan
  • IRCCS Ospedale San Raffaele Turro — Milan

Identifiers

NCT: NCT06975709 · IRCCS San Raffaele Hospital · CET 49-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗