Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Study Overview
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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.

Official Title
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Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea

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

Intervention / Treatment
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* Combination Product: osa treatment
* Other: no treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Combination Product: osa treatment<br>* different treatments can be included<br>|
| Experimental: no treatment<br> | Other: no treatment<br>* no treatment was undergone<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, sleep apnea, temporo-mandibular disorders