Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

NCT ID: NCT04948541

Last Updated: 2021-08-04

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2021-07-15

Brief Summary

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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

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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

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Sleep Apnea Sleep Apnea, Obstructive Sleep Apnea Syndromes Pain Pain, Face Temporomandibular Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

Group Type EXPERIMENTAL

osa treatment

Intervention Type COMBINATION_PRODUCT

different treatments can be included

no treatment

Group Type EXPERIMENTAL

no treatment

Intervention Type OTHER

no treatment was undergone

Interventions

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osa treatment

different treatments can be included

Intervention Type COMBINATION_PRODUCT

no treatment

no treatment was undergone

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anna Alessandri Bonetti

OTHER

Sponsor Role lead

Responsible Party

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Anna Alessandri Bonetti

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 37491568 (View on PubMed)

Other Identifiers

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3928

Identifier Type: -

Identifier Source: org_study_id

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