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NCT04876625 · ClinicalTrials.gov registry record · NA
OA Therapy for Mouth-breathers Who Snore
A NA study, sponsored by Texas A&M University.
- Completed
- Registry status
- NA
- Development phase
- 89
- Enrollment target
NCT04876625 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 89 participants.
The verdict
NCT04876625, a NA study, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- NA
- Development phase
- 89 participants
- Enrollment target
Study 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 d
Interventions
- DEVICE myTAP oral appliance plus mouth shield
- DEVICE myTAP oral appliance alone for first 4 weeks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2022-09-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04876625
The ClinicalTrials.gov registry entry for NCT04876625 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas A&M University, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which myTAP oral appliance plus mouth shield is the first listed.
NCT04876625 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04876625 about?
NCT04876625 is a clinical study titled "OA Therapy for Mouth-breathers Who Snore". 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 breathin...
What is the current status of trial NCT04876625?
This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2019-07-26. Estimated completion is 2022-09-25.
What interventions are being tested in trial NCT04876625?
The interventions under investigation include: myTAP oral appliance plus mouth shield (DEVICE), myTAP oral appliance alone for first 4 weeks (DEVICE).
Who is sponsoring clinical trial NCT04876625?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
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