OA Therapy for Mouth-breathers Who Snore

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 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.

Conditions

• Snoring
• Mouth Breathing
• Obstructive Sleep Apnea

Interventions

DEVICE

myTAP oral appliance plus mouth shield

myTAP anti-snoring oral appliance worn with mouth shield for all 8-weeks; the mouth shield is a comfort accessory that fits over the oral appliance itself and extends into the oral vestibule.

DEVICE

myTAP oral appliance alone for first 4 weeks

myTAP anti-snoring oral appliance worn alone for first 4 weeks followed by wearing it for 4 weeks with the mouth shield

Sponsors & Collaborators

• Texas A&M University

  lead OTHER

Principal Investigators

• Emet Schneiderman, PhD · Texas A&M University College of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-26

Primary Completion

2021-09-25

Completion

2022-09-25

FDA Device

Yes

Countries

• United States

Study Locations