ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

NCT ID: NCT06975709

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorders (TMD) Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Questionnaire and Physical Exam

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luigi Ferini Strambi

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS San Raffaele Hospital

Milan, Italy, Italy

Site Status NOT_YET_RECRUITING

IRCCS Ospedale San Raffaele Turro

Milan, Milano, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Simona Tecco, MD

Role: CONTACT

+390226432970 ext. +39

Luigi Ferini-Strambi, MD

Role: CONTACT

+390226433363 ext. +39

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luigi Ferini Strambi, MD

Role: primary

+390226433363 ext. +39

Luigi Ferini-Strambi, MD

Role: backup

+390226433363 ext. +39

Luigi Ferini Strambi, MD

Role: primary

+390226433363 ext. +39

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CET 49-2025

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRCCS San Raffaele Hospital

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diet and Sleep Monitoring
NCT03257137 COMPLETED NA
Aging, Sleep, Cognitive Process
NCT00804804 COMPLETED NA
Narcolepsy Nightmare Study
NCT05709873 COMPLETED NA
Sleep and Memory in Children
NCT02785328 COMPLETED NA