Obstructive Sleep Apnea
Conditions
Keywords
oral appliance, sleep quality, sleep apnea
Brief summary
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.
Detailed description
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.
Interventions
DEVICEoral appliance - A ; washout; oral appliance B
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.
DEVICEoral appliance - B; washout; oral appliance A
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.
Sponsors
Texas A&M University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OSA PSG or PG diagnosed adults within 1 year * age \>18 * Currently treated with continuous positive airway pressure (CPAP) * AHI ≥ \>30 events/hour of sleep * Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint) * BMI ≥ 30 * At least 8 teeth per arch to support either OA device * Central and mixed apnea index \<5 events/hour * Mallampati score from I to III * Palatine tonsils - grade 0, 1, or 2 * Consent to study's timeline * Willingness to wear home sleep test apparatus for at least 4 nights * Willingness to wear an oral appliance every night for 8 weeks * Willingness to pick up and return home sleep test kits as needed
Exclusion criteria
* Cardiac & pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD); * Central sleep apnea; * Comorbidities with other sleep disorders * No active TMD or jaw muscle pain * Morphological airway abnormalities * Pre-existing difficulty swallowing; throat or neck related health issues * Endocrine dysfunction * Severe psychiatric disorders; * Previous OA therapy; ENT surgery * Restrictions in jaw opening * Pregnancy / breast feeding or intent to become pregnant during the study * Inability to apply the sleep recorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Event Index (REI) at T2 | 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stable Sleep Percent | 4 weeks | Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis |
Countries
United States
Participant flow
Recruitment details
162 individuals screened for eligibility; 62 enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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 | 29 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Additional dental work needed | 1 | 0 |
| Overall Study | Death in family | 0 | 1 |
| Overall Study | Dental sensitivity | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 13 |
| Overall Study | UPPP Surgery | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Oral Appliance Sequence - A -- B | Oral Appliance Sequence B -- A |
|---|---|---|---|
| Age, Continuous | 61.0 years | 64.5 years | 61.0 years |
| Body Mass Index (kg/m^2) | 31.0 kg/m^2 | 30.3 kg/m^2 | 31.0 kg/m^2 |
| Mean SaO2 | 93.0 Percent | 93.0 Percent | 93.1 Percent |
| Minimum SaO2 | 80.0 Percent | 80.0 Percent | 82.0 Percent |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 21 Participants | 22 Participants |
| Respiratory Event Index (events/hr) | 33.7 number of events /hour | 32.6 number of events /hour | 36.1 number of events /hour |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 39 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 36 |
| other Total, other adverse events | 0 / 41 | 1 / 36 |
| serious Total, serious adverse events | 0 / 41 | 0 / 36 |
Outcome results
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Oral Appliance Sequence - A -- B | Respiratory Event Index (REI) at T2 | At T2 (end of 1st 4 wk leg | 12.8 number of events per hour |
| Oral Appliance Sequence - A -- B | Respiratory Event Index (REI) at T2 | At T4 (end of 2nd 4 wk leg) | 9.3 number of events per hour |
| Oral Appliance Sequence B -- A | Respiratory Event Index (REI) at T2 | At T2 (end of 1st 4 wk leg | 21.1 number of events per hour |
| Oral Appliance Sequence B -- A | Respiratory Event Index (REI) at T2 | At T4 (end of 2nd 4 wk leg) | 13.1 number of events per hour |
Comparison: Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.p-value: 0.152Wilcoxon (Mann-Whitney)
Secondary
Stable Sleep Percent
Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis
Time frame: 4 weeks
Population: 20 subject dropped out or were lost to follow-up at T2. An additional 6 dropped out before T4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Appliance Sequence - A -- B | Stable Sleep Percent | At T2 (end of 1st 4 wk leg | 49.35 percentage of high frequency coupling | Standard Deviation 17.7 |
| Oral Appliance Sequence - A -- B | Stable Sleep Percent | At T4 (end of 2nd 4 wk leg | 47.82 percentage of high frequency coupling | Standard Deviation 21.12 |
| Oral Appliance Sequence B -- A | Stable Sleep Percent | At T2 (end of 1st 4 wk leg | 48.7 percentage of high frequency coupling | Standard Deviation 18.3 |
| Oral Appliance Sequence B -- A | Stable Sleep Percent | At T4 (end of 2nd 4 wk leg | 52.38 percentage of high frequency coupling | Standard Deviation 19.67 |