Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02685202
Eligibility Criteria:
Inclusion Criteria:
* Any race or ethnicity
* Meet Research Diagnostic Criteria for TMD to confirm Group II: Masticatory Muscle Disorders, 1A: Myalgia
* Rate their TMD pain severity as ≥4 on a 0-10 numeric rating scale
* Have no history of treatment for OSA.
If taking a prescription medication (with the exception of prescription formulations of NSAIDs, acetaminophen, and aspirin) episodically for the management of pain, the subject must agree to discontinue its use prior to or at the baseline visit. If taking a prescription medication daily for the management of pain, must agree to continue the daily use of the medication throughout the 16-week observation period. If taking an over-the-counter pain medication daily, the subject must agree to continue the daily use throughout the study.
Exclusion Criteria:
* \<8 retained teeth per arch
* Tooth mobility
* Unmanaged periodontal disease
* Skeletal Class III occlusion
* Central sleep apnea
* Hypoventilation syndromes
* Congestive heart failure
* Chronic obstructive pulmonary disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
64 Years
Study:
NCT02685202
Study Brief:
Protocol Section:
NCT02685202