Sleep ApneaNCT04948541
Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders
A study testing osa treatment and no treatment in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Anna Alessandri Bonetti at 1 site in Italy.
Trial summary
Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
- What is being tested?
- osa treatment and no treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment
Who cannot join
- patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination
- patients presenting dental problems
- patients assuming medications that would alter pain perception
- patients not signing the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea
Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
Read the detailed description
Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Pain, Pain, Face, Temporomandibular Disorder
- Being tested
- osa treatment, no treatment
- Keywords
- pain, sleep apnea, temporo-mandibular disorders
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Pain, Facial Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osa treatmentCombination product
different treatments can be included
no treatmentOther
no treatment was undergone
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Combination Product: osa treatment |
| no treatment | Experimental | Not described Receives: Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
prevalence described as percentage of people having the disease
Measured: change from baseline temporo-mandibular disorders at 18 months
Secondary outcomes (2)
change in TMD signs according to diagnostic criteria for temporo-mandibular disorder
reduction described as percentage of people resolving the disease
Measured: change from baseline temporo-mandibular disorder signs at 18 months
change in TMD symptoms according to diagnostic criteria for temporo-mandibular disorder
reduction in pain described by patients through a numeric rating scale going from 0 to 10, were 0 is no pain and 10 is the worst immaginabile pain
Measured: change from baseline temporo-mandibular disorder symptoms at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start21 Apr 2021
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Alessandri Bonetti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Alessandri Bonetti, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948541
- Sponsor's protocol ID
- 3928
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alessandri-Bonetti A, Lobbezoo F, Mangino G, Aarab G, Gallenzi P. Obstructive sleep apnea treatment improves temporomandibular disorder pain. Sleep Breath. 2024 Mar;28(1):203-209. doi: 10.1007/s11325-023-02883-4. Epub 2023 Jul 25.
PubMed 37491568
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea
- ClinicalTrials.gov ID
- NCT04948541
- Acronym / sponsor ID
- 3928
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Pain, Pain, Face, Temporomandibular Disorder
- Keywords
- pain, sleep apnea, temporo-mandibular disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anna Alessandri BonettiUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Jul 2021 (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.
Aims of this research are to detect if an improvement in sleep pattern in patients suffering from obstructive sleep apnea (OSA), produces a reduction in pain and dysfunction in the orofacial area by examining variation in temporo-mandibular disorder (TMD) signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
Detailed description
Since a bidirectional relationship has been suggested for poor sleep and pain and considering that patients suffering from obstructive sleep apnea (OSA) have been reported to present a higher prevalence of temporo-mandibular disorder (TMD) signs and symptoms compared to healthy controls; aims of this research are to detect if an improvement in sleep pattern in patients suffering from OSA, produces a reduction in pain and dysfunction in the orofacial area by examining variation in TMD signs and symptoms and if the prevalence of TMDs in OSA patients controlling this disease decreases to levels comparable to healthy subjects.
41 OSA patients will undergo a complete TMD examination prior to start any OSA treatment and after at least 18 months of therapy. Variations in TMD signs and symptoms will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Combination Product: osa treatment |
| no treatment | Experimental | Other: no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment
Key exclusion criteria (4 listed)
- patients presenting some kind of cognitive impairment, due to difficulties in undergoing TMD examination
- patients presenting dental problems
- patients assuming medications that would alter pain perception
- patients not signing the informed consent
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 |
|---|---|---|
| osa treatmentdifferent treatments can be included | Combination product | treatment |
| no treatmentno treatment was undergone | Other | no treatment |
Primary outcome
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
Time frame: change from baseline temporo-mandibular disorders at 18 months
prevalence described as percentage of people having the disease
2 secondary outcomes
change in TMD signs according to diagnostic criteria for temporo-mandibular disorder
Time frame: change from baseline temporo-mandibular disorder signs at 18 months
change in TMD symptoms according to diagnostic criteria for temporo-mandibular disorder
Time frame: change from baseline temporo-mandibular disorder symptoms at 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 37491568Alessandri-Bonetti A, Lobbezoo F, Mangino G, Aarab G, Gallenzi P. Obstructive sleep apnea treatment improves temporomandibular disorder pain. Sleep Breath. 2024 Mar;28(1):203-209. doi: 10.1007/s11325-023-02883-4. Epub 2023 Jul 25.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osa treatment and no treatment in people with Sleep Apnea and Sleep Apnea, Obstructive, run by Anna Alessandri Bonetti at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders (time frame: change from baseline temporo-mandibular disorders at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948541, which also lists 1 linked publication.
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 18 Mar 2026.