Actively Recruiting

Age: 18Years +
All Genders
ID06975709

Association Between Temporomandibular Disorders and Sleep Disorders

Led by IRCCS San Raffaele · Updated on 2025-05-16

100

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the link between temporomandibular disorders (TMD), which cause pain and dysfunction in the jaw muscles and joints, and various sleep disorders. The study aims to find out how common TMD is among patients who have been diagnosed with sleep disorders such as insomnia, hypersomnia, restless legs syndrome, and sleep apnea. This observational study is sponsored by IRCCS San Raffaele and focuses on understanding these conditions to improve patient care. Participants will undergo diagnostic questionnaires and physical examinations to assess the presence of TMD. These questionnaires will be given to patients who have a confirmed sleep disorder diagnosis from specialized centers. The study involves patients from outpatient clinics specializing in neurology and sleep disorders, as well as dentistry. The main study procedures occur at enrollment when the primary and secondary outcomes are measured. During the study, participants will complete questionnaires and physical exams to evaluate their jaw and sleep health. Researchers will analyze their responses to better understand how TMD relates to sleep disorders. The study also involves reviewing patient histories and monitoring various symptoms. Participants must provide informed consent and complete privacy forms. The research team will focus on outcomes measured at enrollment, with no additional long-term follow-up described. The total participation time will depend on the enrollment and assessment process.

CONDITIONS

Brief Title

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Female and Male
  • Signature of the privacy information form
  • Signature of the informed consent form of the protocol
  • Subjects capable of understanding and willing to participate
  • Subjects diagnosed with a sleep disorder such as insomnia, hypersomnia, restless legs syndrome, REM sleep behavior disorder, narcolepsy, obstructive sleep apnea syndrome, primary snoring, REM parasomnias, or nocturnal epilepsy
Not Eligible

You will not qualify if you...

  • Physical trauma to the head and neck area
  • Painful oral conditions like pulpitis, tooth fractures, abscesses, tooth decay, canker sores, or mucosal wounds
  • Recent dental treatments causing pain such as tooth extraction or root canal
  • Use of oral contraceptives
  • Subjects not capable of understanding or willing to participate
  • Patients with neurological disorders interfering with questionnaire completion or psychiatric conditions or drug use according to DSM-5 criteria, including schizophrenia, bipolar disorder, major depression, substance abuse, or personality disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At enrollment

Participants complete diagnostic questionnaires and physical exams to assess the presence of temporomandibular disorders in patients with sleep disorders.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

IRCCS San Raffaele Hospital

Milan, Italy, Italy, 20132

Not Yet Recruiting

2

IRCCS Ospedale San Raffaele Turro

Milan, Milano, Italy, 20127

Actively Recruiting

Loading map...

Research Team

S

Simona Tecco, MD

L

Luigi Ferini-Strambi, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here