Trial Outcomes & Findings for Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea (NCT NCT02685202)
NCT ID: NCT02685202
Last Updated: 2017-11-14
Results Overview
Weekly mean pain index is computed as the arithmetic mean of daily pain index values recorded at enrollment and then at the end of each week throughout the 16 week observation period. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale) where percentage refers to the percent of waking day that the participant had facial pain) as reported in the Daily Symptom Diary. It is computed from the weekly mean pain index (numeric rating scale 0-10), and representing the arithmetic mean of daily pain index values in the preceding 7-day period. The pain index for any given day is the product of the pain intensity score multiplied by the pain duration score, each as reported in the Daily Symptom Diary kept by the subject.
TERMINATED
NA
9 participants
Baseline, 16 weeks
2017-11-14
Participant Flow
Participant milestones
| Measure |
Mandibular Advancement Splint
An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position
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.
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|---|---|
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Overall Study
STARTED
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9
|
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Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Mandibular Advancement Splint
An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
Baseline Characteristics
Temporomandibular Disorder (TMD) Pain in Response to Jaw Advancement in People With TMD and Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Mandibular Advancement Splint
n=9 Participants
An oral appliance which is standard of care in treating mild or moderate obstructive sleep apnea by repositioning the mandible in a forward position
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
53. years
STANDARD_DEVIATION 2.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksPopulation: No participants could be reached to obtain pain symptom diary information; therefore, data for this outcome measure are unavailable.
Weekly mean pain index is computed as the arithmetic mean of daily pain index values recorded at enrollment and then at the end of each week throughout the 16 week observation period. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") multiplied by pain duration (0-100 percentage scale) where percentage refers to the percent of waking day that the participant had facial pain) as reported in the Daily Symptom Diary. It is computed from the weekly mean pain index (numeric rating scale 0-10), and representing the arithmetic mean of daily pain index values in the preceding 7-day period. The pain index for any given day is the product of the pain intensity score multiplied by the pain duration score, each as reported in the Daily Symptom Diary kept by the subject.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: No participants could be reached to obtain apnea and hypopneas sums; therefore, data for this outcome measure are unavailable.
The AHI is the sum of the number of apneas and hypopneas recorded during the home sleep test per hour of recorded sleep. The AHI is used to indicate the severity of obstructive sleep apnea.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: No participants could be reached to obtain ESS scores; therefore, data for this outcome measure are unavailable.
Daytime sleepiness will be assessed using the ESS which is based on responses to self-administered questions that assess the propensity of the subject to fall asleep in 8 everyday situations (e.g., sitting and reading, talking to someone, being stopped in traffic). Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness.
Outcome measures
Outcome data not reported
Adverse Events
Mandibular Advancement Splint
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne E. Sanders, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place