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Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea

NCT02685202 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-11-14

Study results available
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Summary

The purpose of this study is to characterize the course of temporomandibular disorder (TMD) pain in adults with TMD and obstructive sleep apnea (OSA), all of whom are being treated with mandibular advancement splint (MAS) therapy.

Study participants are 12 adults with painful TMD and comorbid mild to moderate OSA (apnea-hypopnea index ≥5 and \<30).

This is an interventional study in which 12 patients receive MAS therapy for comorbid TMD/OSA for 16 weeks. It is standard of care to treat mild or moderate OSA with MAS therapy, the the effect on MAS therapy on TMD pain in people with OSA is unknown. There is no comparison group. Care is being provided under the direction of a sleep physician by a dentist who specializes in dental sleep medicine. The investigators expect that as MAS therapy reduces the severity of OSA, painful TMD symptoms will also reduce.

Conditions

  • Myalgia
  • Apnea, Obstructive Sleep

Interventions

DEVICE

Mandibular advancement splint

A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Anne E Sanders, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685202 on ClinicalTrials.gov