Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

March 16, 2026 updated by: Anna Alessandri Bonetti

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
Combination product: osa treatment
different treatments can be included
Experimental: no treatment
Other: no treatment
no treatment was undergone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline temporo-mandibular disorders at 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in TMD signs according to diagnostic criteria for temporo-mandibular disorder
Time Frame: change from baseline temporo-mandibular disorder signs at 18 months
reduction described as percentage of people resolving the disease
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
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
change from baseline temporo-mandibular disorder symptoms at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Alessandri Bonetti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 27, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3928

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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