Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

NCT04948541 | Completed

• 1 other identifier: 3928
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pain; sleep apnea; temporo-mandibular disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• change in TMD signs according to diagnostic criteria for temporo-mandibular disorder

  change from baseline temporo-mandibular disorder signs at 18 months

• change in TMD symptoms according to diagnostic criteria for temporo-mandibular disorder

  change from baseline temporo-mandibular disorder symptoms at 18 months

Study Arms (2)

treatment

EXPERIMENTAL

Combination Product: osa treatment

no treatment

EXPERIMENTAL

Other: no treatment

Interventions

osa treatment COMBINATION_PRODUCT

different treatments can be included

treatment

no treatment OTHER

no treatment was undergone

no treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suffering from OSA diagnosed by polysomnography not yet undergoing treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Alessandri Bonetti: lead

Study Sites (1)

Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Related Publications (1)

• 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.

  PMID: 37491568 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pain; Facial Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 2, 2021
• Study Start: April 21, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IT (1)