OA Therapy for Mouth-breathers Who Snore

NCT04876625 | Completed FDA Device

• 1 other identifier: IRB2019-0421
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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 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

Keywords

oral appliance; mouth shield; snoring

Outcome Measures

Primary Outcomes (1)

• Respiratory Event Index (REI) at T2

  Number of apneas and hypopneas per hour of recording using the NOX T3 sleep recording system at T2 (4 weeks). REI is reported instead of Apnea Hypopnea Index (AHI), as it is a more appropriate measure for home sleep testing. Apneas are scored when there is a 90% drop in the flow signal between 10 and 120 seconds. Hypopneas are scored when there is a 30% drop in flow signal between 10 and 120 seconds followed by either a drop in oxygen saturation or an arousal.

  4 weeks

Study Arms (2)

OA plus MS 8wk

EXPERIMENTAL

Oral Appliance plus Mouth Shield for 8-weeks

Device: myTAP oral appliance plus mouth shield

OA Alone 4wk

ACTIVE COMPARATOR

Oral Appliance is used alone for first 4 weeks followed by 4 weeks of Oral Appliance plus Mouth Shield

Device: myTAP oral appliance alone for first 4 weeks

Interventions

myTAP oral appliance plus mouth shield DEVICE

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.

Also known as: anti-snoring device, midline traction oral appliance

OA plus MS 8wk

myTAP oral appliance alone for first 4 weeks DEVICE

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

Also known as: anti-snoring device, midline traction oral appliance

OA Alone 4wk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• Hoekema A, Doff MH, de Bont LG, van der Hoeven JH, Wijkstra PJ, Pasma HR, Stegenga B. Predictors of obstructive sleep apnea-hypopnea treatment outcome. J Dent Res. 2007 Dec;86(12):1181-6. doi: 10.1177/154405910708601208.

  PMID: 18037652 BACKGROUND

MeSH Terms

Conditions

Snoring; Mouth Breathing; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Emet Schneiderman, PhD

  Texas A&M University College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators scoring sleep studies and doing data analysis will be blinded with regard to group identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single center, randomized trial using a parallel group design

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: July 26, 2019
• Primary Completion: September 25, 2021
• Study Completion: September 25, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

US (1)