Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Pain, Face; Temporomandibular Disorder; Sleep Apnea; Pain; Sleep Apnea, Obstructive
• Interventions: Other: no treatment; Combination Product: osa treatment

• Registration Number: NCT04948541
• Lead Sponsor: Anna Alessandri Bonetti

Brief 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.

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 Timeline

• Study Start: 2021-04-21
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-27
• Primary Completion: 2021-06-30
• Status Verified: 2021-07
• Study First Posted: 2021-07-02
• Study Completion: 2021-07-15
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
no treatment	no treatment	-
treatment	osa treatment	-

Primary Outcome Measures

Name	Time	Method
variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders	change from baseline temporo-mandibular disorders at 18 months	prevalence described as percentage of people having the disease

Secondary Outcome Measures

Name	Time	Method
reduction of TMD signs according to diagnostic criteria for temporo-mandibular disorder	change from baseline temporo-mandibular disorder signs at 18 months	reduction described as percentage of people resolving the disease
reduction of TMD symptoms according to diagnostic criteria for temporo-mandibular disorder	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

Trial Locations

Locations (1)

Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, RM, Italy