Temporomandibular Disorders (TMD)Gnathology TMDNCT06975709
ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS
An observational study of Temporomandibular Disorders (TMD) and Sleep, run by IRCCS San Raffaele at 2 sites in Italy.
Trial summary
ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMD), Sleep
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population must include Female and Male over 18 y.o with sleep disorders that meet inclusion and exclusion criteria.
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS San Raffaele Hospital
Milan, Italy, 20132
Luigi Ferini Strambi, MD, +390226433363 ext. +39, ferinistrambi.luigi@hsr.it
Luigi Ferini-Strambi, MD, +390226433363 ext. +39, ferinistrambi.luigi@hsr.it
- Recruiting
IRCCS Ospedale San Raffaele Turro
Milan, Milano, 20127
Luigi Ferini Strambi, MD, +390226433363 ext. +39, ferinistrambi.luigi@hsr.it
About this study
ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS
Read the 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.
- Conditions
- Temporomandibular Disorders (TMD), Sleep
- Being tested
- Questionnaire and Physical Exam
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at enrollment
Secondary outcomes (1)
Secondary Outcome
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.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Ferini Strambi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975709
- Sponsor's protocol ID
- IRCCS San Raffaele Hospital
- Other IDs
- CET 49-2025
- Acronym
- Gnathology TMD
- Status last verified
- May 2025
- First submitted
- 28 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSOCIATION BETWEEN TEMPOROMANDIBULAR DISORDERS AND SLEEP DISORDERS
- ClinicalTrials.gov ID
- NCT06975709
- Acronym / sponsor ID
- Gnathology TMD / IRCCS San Raffaele Hospital
- Conditions
- Temporomandibular Disorders (TMD), Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with TMD | – | Other: Questionnaire and Physical ExamTemporomandibular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population must include Female and Male over 18 y.o with sleep disorders that meet inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamThe 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. | Other | patients with TMD |
Primary outcome
Primary Outcome
Time frame: 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
1 secondary outcome
Secondary Outcome
Time frame: at enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMD) and Sleep, run by IRCCS San Raffaele at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona Tecco, MD (+390226432970 ext. +39, tecco.simona@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.