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NCT04948541 Clinical Trial

Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04948541
Other study ID # 3928
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date July 15, 2021

Study information
Verified date July 2021
Source Catholic University of the Sacred Heart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 15, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• osa treatment
different treatments can be included
Other:
• no treatment
no treatment was undergone

Locations
Country Name City State
Italy Policlinico Universitario A. Gemelli IRCCS Roma RM

Sponsors (1)
Lead Sponsor Collaborator
Anna Alessandri Bonetti

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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