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NCT Number: NCT04948541

Effect Of Sleep Apnea Treatment On Temporo-Mandibular Disorders

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.

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Key information

Conditions

Sleep Apnea Apnea Craniomandibular Disorders Dyssomnias Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pain, Face Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Temporomandibular Disorder Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osa treatment

Combination Product

different treatments can be included

No treatment

Other

no treatment was undergone

Primary outcomes

  1. variation in TMD prevalence according to diagnostic criteria for temporo-mandibular disorders

    Time frame: change from baseline temporo-mandibular disorders at 18 months

    prevalence described as percentage of people having the disease

Secondary outcomes

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

    Time frame: change from baseline temporo-mandibular disorder signs at 18 months

    reduction described as percentage of people resolving the disease

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Anna Alessandri Bonetti

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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