Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.
The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral appliance - A | Experimental | Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX |
|
| Oral appliance - B | Experimental | Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral appliance - A ; washout; oral appliance B | Device | Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Event Index (REI) at T2 | Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stable Sleep Percent | Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emet Schneiderman, PhD | Texas A&M University College of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University College of Dentistry | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32942939 | Result | Schneiderman E, Schramm P, Hui J, Wilson PD, Moura P, German Z, McCann A, Newton M. Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management. J Dent Res. 2021 Feb;100(2):155-162. doi: 10.1177/0022034520956977. Epub 2020 Sep 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
162 individuals screened for eligibility; 62 enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oral Appliance Sequence A-B | Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX Used Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX |
| FG001 | Oral Appliance Sequence B-A | Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
31 subjects assigned to each oral appliance (OA) sequence group in cross-over design. 6 left study prior to receipt of OA, so demographics reflect those 56 subjects who received the intervention. See figure 1 in publication for details.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oral Appliance Sequence - A -- B | Group STARTING with Appliance A for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX. One week washout with no oral appliance usage. Used Appliance B for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Event Index (REI) at T2 | Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing. | 20 subjects dropped out or were lost to follow-up by T2. An additional 6 dropped out before T4, bringing the total number of dropouts to 26. | Posted | Median | Inter-Quartile Range | number of events per hour | 4 weeks |
|
Each participant participated for 9 weeks, for which time adverse event data were collected.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Appliance A | Oral Appliance A - Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX. Worn for 4 weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral appliance intolerance | General disorders | Non-systematic Assessment | Intolerance to oral appliance therapy due to dental sensitivity. This occurred in a subject in Sequence B-A in response to oral appliance B during the first leg of the study. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emet Schneiderman | Texas A&M University College of Dentistry | 2148288377 | eschneiderman@tamu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2019 | May 20, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2018 | May 20, 2021 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| oral appliance - B; washout; oral appliance A | Device | Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. |
|
|
| UPPP Surgery |
|
| Dental sensitivity |
|
| Death in family |
|
| BG001 | Oral Appliance Sequence B -- A | Group STARTING with Appliance B for first leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX. One week washout with no oral appliance usage. Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (kg/m^2) | Median | Inter-Quartile Range | kg/m^2 |
|
| Respiratory Event Index (events/hr) | Number of respiratory events per hour (number of apnea-hypopnea events divided by the number of recorded hours) | Median | Inter-Quartile Range | number of events /hour |
|
| Mean SaO2 | Mean percentage of oxygen saturation values were obtained from each subject using pulse oximetry. Collectively these were not normally distributed so were summarized with the median and interquartile range. | Median | Inter-Quartile Range | Percent |
|
| Minimum SaO2 | Minimum oxygen percentage saturation values were obtained for each subject using pulse oximetry. Collectively these were not normally distributed so were summarized with the median and interquartile range. | Median | Inter-Quartile Range | Percent |
|
| OG001 | Oral Appliance Sequence B -- A | Group STARTING with Appliance B for 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX Used Appliance A for second leg of 4 weeks: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. Used for period of first 4 weeks. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX |
|
|
|
| Secondary | Stable Sleep Percent | Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis | 20 subject dropped out or were lost to follow-up at T2. An additional 6 dropped out before T4. | Posted | Mean | Standard Deviation | percentage of high frequency coupling | 4 weeks |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Oral Appliance B | Oral Appliance B: Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX. Worn for 4 weeks. | 0 | 36 | 0 | 36 | 1 | 36 |
|
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| At T4 (end of 2nd 4 wk leg |
|
|