Clinical trial NCT04948541: Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders
Official title: Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders In Patients Suffering From Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Pain
Pain, Face
Temporomandibular Disorder
Keywords: pain
sleep apnea
temporo-mandibular disorders
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders
timeFrame: change from baseline temporo-mandibular disorders at 18 months
Secondary outcomes:
measure: reduction of TMD signs according to diagnostic criteria for temporo-mandibular disorder
timeFrame: change from baseline temporo-mandibular disorder signs at 18 months
measure: reduction of TMD symptoms according to diagnostic criteria for temporo-mandibular disorder
timeFrame: change from baseline temporo-mandibular disorder symptoms at 18 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References: