Status:
COMPLETED
OA Therapy for Mouth-breathers Who Snore
Lead Sponsor:
Texas A&M University
Conditions:
Snoring
Mouth Breathing
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Breathing is one of the body's vital functions that occur under normal conditions using the nose. When humans breathe primarily through the mouth instead of the nose, this is referred to as mouth brea...
Detailed Description
Background: Respiration is one of the body's vital functions that occurs under normal conditions using the nose. When nasal breathing is supplemented by or supplanted through the mouth, this is referr...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- At least 18 years old (adults \& seniors, male \& female).
- Presence of snoring, mouth-breathing or previously diagnosed with obstructive sleep apnea.
- If present, stable cardiopulmonary disease (heart failure, chronic obstructive pulmonary disease, ventricular dysrhythmia), morbid obesity or other serious health conditions, must be under a physician's care; participant must obtain written permission from the physician to participate in this study.
- If participated in recent OA clinical trial at the Texas A\&M University College of Dentistry (IRB# 2017-0390) must be willing to try the myTAP as alternative to OA that is currently being used. The myTAP is a chairside-fitted OA that may be more comfortable and effective than the previous OAs and includes a mouth-shield.
- At least 8 teeth per arch to support OA device.
- Mallampati score from I to III; palatine tonsils grade 0,1 or 2.
- Willing \& able to provide verbal \& written informed consent in English \& understand how to apply, remove \& utilize the sleep recorder \& the OA device, as well as fill out brief questionnaires \& nightly sleep diary.
- Exclusion Criteria:
- Unable or unwilling to complete the study demands \& schedule.
- Active temporomandibular joint dysfunction (TMD) or jaw muscle pain, morphological airway abnormalities.
- Severe restrictions in jaw opening.
- Pre-existing difficulty swallowing; throat or neck related health issues; unmanaged endocrine dysfunction.
- Severe chronic nasal obstruction that precludes possibility of nasal breathing.
- Severe psychiatric \& neurological disorders; intellectually disabled.
- Advanced periodontal disease (e.g., loose teeth).
- History of uvulopalatopharyngoplasty (UPPP) surgery.
- Loose teeth, loose crowns or fillings.
- Removable dentures or bridges.
- Temporary crowns.
- Orthodontic braces.
- Other oral conditions which would be adversely affected by wearing dental appliances.
Exclusion
Key Trial Info
Start Date :
July 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04876625
Start Date
July 26 2019
End Date
September 25 2022
Last Update
May 22 2023
Active Locations (1)
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1
Texas A&M University College of Dentistry
Dallas, Texas, United States, 75246