OA Therapy for Mouth-breathers Who Snore

Completed · Not applicable

Conditions studied: Snoring, Mouth Breathing, Obstructive Sleep Apnea

In brief

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 breathing. Snoring and obstructive sleep apnea (OSA) occur frequently in mouth breathers. Mouth breathing impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. Serious health conditions associated with an obstructed upper airway in those who snore include hypertension, cardiovascular disease and mild cognitive impairment. Oral appliances (OAs) that bring the lower jaw (mandible) forward have been shown to be highly effective in reducing snoring and interruptions in breathing (respiratory events) that occur in those who snore and/or have OSA. The myTAP™ OA (AMI, Dallas, TX) includes an optional mouth shield (MS) that is anticipated to promote nasal breathing. The purpose of this study is to investigate the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics (breathing and heart activity) and their effect on improving OSA and oral health, especially of the periodontal tissues, in confirmed mouth breathers who snore and/or have OSA. As many as 70 adults at least 18 years old will be recruited to participate. All participants will wear the OA during sleep for 8 weeks (Phase 1). Half of the participants will be randomly assigned to wear the OA only for the first 4 weeks; all will wear both the OA and MS for the last 4 weeks. Participants will wear an easy-to-use home sleep recording system (NOX T3) for 2 nights at the start of the study and again at 4 weeks and 8 weeks. Based on the investigators' experience, some participants will not have achieved maximal benefit from the OA at 8 weeks, and will require addition adjustment. These participants will enter a second phase of the study where they will have 1 or more sleep studies done at 2 week intervals, and will further adjust their OAs (that is, advance the mandible) to eliminate snoring.

Key facts

Study ID

NCT04876625

Run by

Texas A&M University

People needed

89

Starts

2019-07-26

Expected to finish

2022-09-25

Last updated by the study team

2023-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Texas A&M University College of Dentistry — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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