Trial Outcomes & Findings for Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality (NCT NCT03219034)
NCT ID: NCT03219034
Last Updated: 2022-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
4 weeks
Results posted on
2022-01-10
Participant Flow
162 individuals screened for eligibility; 62 enrolled.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
13
|
|
Overall Study
Additional dental work needed
|
1
|
0
|
|
Overall Study
UPPP Surgery
|
1
|
0
|
|
Overall Study
Dental sensitivity
|
0
|
1
|
|
Overall Study
Death in family
|
0
|
1
|
Baseline Characteristics
Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality
Baseline characteristics by cohort
| Measure |
Oral Appliance Sequence - A -- B
n=27 Participants
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.
|
Oral Appliance Sequence B -- A
n=29 Participants
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
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
30.3 kg/m^2
n=5 Participants
|
31.0 kg/m^2
n=7 Participants
|
31.0 kg/m^2
n=5 Participants
|
|
Respiratory Event Index (events/hr)
|
32.6 number of events /hour
n=5 Participants
|
36.1 number of events /hour
n=7 Participants
|
33.7 number of events /hour
n=5 Participants
|
|
Mean SaO2
|
93.0 Percent
n=5 Participants
|
93.1 Percent
n=7 Participants
|
93.0 Percent
n=5 Participants
|
|
Age, Continuous
|
64.5 years
n=5 Participants
|
61.0 years
n=7 Participants
|
61.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Minimum SaO2
|
80.0 Percent
n=5 Participants
|
82.0 Percent
n=7 Participants
|
80.0 Percent
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Oral Appliance Sequence - A -- B
n=21 Participants
Group STARTING with this appliance: 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.
1 week washout followed by 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
|
Oral Appliance Sequence B -- A
n=21 Participants
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
|
|---|---|---|
|
Respiratory Event Index (REI) at T2
At T2 (end of 1st 4 wk leg
|
12.8 number of events per hour
Interval 7.5 to 26.7
|
21.1 number of events per hour
Interval 9.8 to 31.2
|
|
Respiratory Event Index (REI) at T2
At T4 (end of 2nd 4 wk leg)
|
9.3 number of events per hour
Interval 7.7 to 15.5
|
13.1 number of events per hour
Interval 10.4 to 16.6
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 20 subject dropped out or were lost to follow-up at T2. An additional 6 dropped out before T4.
Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis
Outcome measures
| Measure |
Oral Appliance Sequence - A -- B
n=21 Participants
Group STARTING with this appliance: 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.
1 week washout followed by 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
|
Oral Appliance Sequence B -- A
n=21 Participants
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
|
|---|---|---|
|
Stable Sleep Percent
At T2 (end of 1st 4 wk leg
|
49.35 percentage of high frequency coupling
Standard Deviation 17.70
|
48.7 percentage of high frequency coupling
Standard Deviation 18.3
|
|
Stable Sleep Percent
At T4 (end of 2nd 4 wk leg
|
47.82 percentage of high frequency coupling
Standard Deviation 21.12
|
52.38 percentage of high frequency coupling
Standard Deviation 19.67
|
Adverse Events
Oral Appliance A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Appliance B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Appliance A
n=41 participants at risk
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.
|
Oral Appliance B
n=36 participants at risk
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.
|
|---|---|---|
|
General disorders
Oral appliance intolerance
|
0.00%
0/41 • Each participant participated for 9 weeks, for which time adverse event data were collected.
|
2.8%
1/36 • Each participant participated for 9 weeks, for which time adverse event data were collected.
|
Additional Information
Dr. Emet Schneiderman
Texas A&M University College of Dentistry
Phone: 2148288377
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place