Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876625
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2021-04-29
Brief Title:
OA Therapy for Mouth-breathers Who Snore
Sponsor:
Texas AM University
Organization:
Texas AM University
Study Overview
Official Title:
Effects of myTAP Oral Appliance Therapy on Cardio-respiratory Dynamics in Mouth-breathers Who Snore
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OATMB
Brief Summary:
Breathing is one of the bodys 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 andor 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 andor 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
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 andor 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 andor 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
Detailed Description:
Background Respiration is one of the bodys vital functions that occurs under normal conditions using the nose When nasal breathing is supplemented by or supplanted through the mouth this is referred to as mouth breathing Primary snoring and obstructive sleep apnea OSA are frequent findings in mouth breathers regardless of age In children mouth breathing is often associated with enlarged adenoids and tonsils changes in body posture hyperactivity attention deficit and impaired learning In all ages 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 Symptoms associated with an obstructed upper airway in those who snore include hypertension cardiovascular disease and mild cognitive impairment There are currently no data on the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics and their effect on improving OSA and oral health especially periodontal health in mouth breathers
Methods Evaluation of the effects of the FDA cleared MyTAP midline traction type oral appliance OA AMI Dallas TX in combination with its FDA-cleared mouth shield MS in treating confirmed mouth breathers who snore andor have OSA
Power analysis Sample size n40 is based on a-posteriori power of 80 observed in the investigative teams recently completed randomized controlled trial RCT comparing two OA designs As many as 70 participants will be enrolled to account for drop-outs
Design Single center prospective randomized clinical trial using a parallel group design
Randomization Using an online randomizer software half of the subjects will be assigned to Group OA plus MS 8wk OA use with MS for 8-weeks and group OA Alone 4wk no MS for first 4-weeks The OA Alone 4wk group will add MS use after 4-weeks and continue to use the combination for subsequent 4-weeks
Clinically standard periodontal exams will be performed at baseline T0 after 4-weeks T2 and after 8 weeks T3 The dentist-fitted OA will be applied chair-side and adjusted to a starting position of 60 of the lower jaws maximum comfortable protrusion All participants will wear the OA nightly during sleep for 8-consecutive weeks Subjects will be instructed to advance the jaw up to 05 mm every 2 nights less frequently if needed to minimize transient discomfort Subjects will use the EverSleep Wearable Sleep Tracker app Somno Health Inc Golden CO on their smart phones to monitor their own snoring nightly and self-titrate their OAs until no snore detection is reported by the software
Based on the investigators recently completed study IRB2017-0390 and another study published on this kind of appliance some participants will not have achieved maximal benefit from the OA and will require addition adjustment These participants will enter Phase 2 of the study where they will have 1 or 2 more sleep studies done at 2 week intervals and will further adjust their OAs that is advance their lower jaws to eliminate snoring
The investigators will evaluate differences in sleep respiration events snoring and other measures at all time points except T1 Periodontal exams gums and supporting tissues will be performed at T1-T3 and T5 Comparison will be done between and within group that is with and without the MS
The purpose of collecting sleep data with OA use is to determine its success in promoting stable respiration during sleep and reducing the number of events in which breathing stops apneas or diminished hypopneas and the amount of oxygen in the blood is low oxygen desaturation
The sleep recorder NOX T3 Nox Medical Reykjavík Iceland is a Food and Drug Administration FDA cleared and certified for sale within the European Economic area CE marked The midline traction oral appliance myTAP AMI Inc Dallas Texas is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared and CE marked The EverSleep device Somnohealth Golden Colorado is a wearable sleep coaching device and is not an FDA 510k cleared medical device
Methods Evaluation of the effects of the FDA cleared MyTAP midline traction type oral appliance OA AMI Dallas TX in combination with its FDA-cleared mouth shield MS in treating confirmed mouth breathers who snore andor have OSA
Power analysis Sample size n40 is based on a-posteriori power of 80 observed in the investigative teams recently completed randomized controlled trial RCT comparing two OA designs As many as 70 participants will be enrolled to account for drop-outs
Design Single center prospective randomized clinical trial using a parallel group design
Randomization Using an online randomizer software half of the subjects will be assigned to Group OA plus MS 8wk OA use with MS for 8-weeks and group OA Alone 4wk no MS for first 4-weeks The OA Alone 4wk group will add MS use after 4-weeks and continue to use the combination for subsequent 4-weeks
Clinically standard periodontal exams will be performed at baseline T0 after 4-weeks T2 and after 8 weeks T3 The dentist-fitted OA will be applied chair-side and adjusted to a starting position of 60 of the lower jaws maximum comfortable protrusion All participants will wear the OA nightly during sleep for 8-consecutive weeks Subjects will be instructed to advance the jaw up to 05 mm every 2 nights less frequently if needed to minimize transient discomfort Subjects will use the EverSleep Wearable Sleep Tracker app Somno Health Inc Golden CO on their smart phones to monitor their own snoring nightly and self-titrate their OAs until no snore detection is reported by the software
Based on the investigators recently completed study IRB2017-0390 and another study published on this kind of appliance some participants will not have achieved maximal benefit from the OA and will require addition adjustment These participants will enter Phase 2 of the study where they will have 1 or 2 more sleep studies done at 2 week intervals and will further adjust their OAs that is advance their lower jaws to eliminate snoring
The investigators will evaluate differences in sleep respiration events snoring and other measures at all time points except T1 Periodontal exams gums and supporting tissues will be performed at T1-T3 and T5 Comparison will be done between and within group that is with and without the MS
The purpose of collecting sleep data with OA use is to determine its success in promoting stable respiration during sleep and reducing the number of events in which breathing stops apneas or diminished hypopneas and the amount of oxygen in the blood is low oxygen desaturation
The sleep recorder NOX T3 Nox Medical Reykjavík Iceland is a Food and Drug Administration FDA cleared and certified for sale within the European Economic area CE marked The midline traction oral appliance myTAP AMI Inc Dallas Texas is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared and CE marked The EverSleep device Somnohealth Golden Colorado is a wearable sleep coaching device and is not an FDA 510k cleared medical device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None