Cleft Palate, Tube Disorders Eustachian, Velopharyngeal Incompetence Due to Cleft Palate, Velopharyngeal Insufficiency
Conditions
Keywords
Otitis media, Eustachian tube, Eustachian tube dysfunction, Eustachian tube function testing, Middle ear ventilation
Brief summary
Elevation of the soft palate (the soft part of the roof of the mouth) during swallowing helps the Eustachian tube to open and keep the ear healthy. (The Eustachian tube is the normal tube running from the middle ear to the back of the nose and throat). When the soft palate does not move enough (due to a history of cleft palate or for unknown reasons), this can lead to speech problems. Also, because the Eustachian tube is not opening enough, fluid can accumulate in the middle ear, which requires treatment with ear tubes. The goal of this research study is to determine if soft palate exercises will help improve the ability of the soft palate to close the area between the throat and nose, like it is supposed to during speech and swallowing, and if this improves Eustachian tube opening.
Detailed description
This trial will look at the feasibility and effect of device-assisted soft palate exercises for the treatment of chronic Eustachian tube (ET) dysfunction (ETD) in older children still experiencing middle-ear disease. Children with or without cleft palate (CP) with ventilation tubes (VTs) will be evaluated for the function of the soft palate and the ET. Subjects with active muscular ETD and inadequate soft palate closure will be prescribed soft palate strengthening exercises for at least 2 months. The objective of the study is to demonstrate the effect of exercises on soft palate closure and ETF. This pilot study will enroll 30 children between ages 6-17 years with VTs or post-VT extrusion tympanic membrane (TM) perforations. All 30 children will have ETD, with active muscular dysfunction. 15 subjects will have a history of cleft palate (CP) and 15 no history of CP. Subjects will undergo history, physical examination including an ENT exam, video-otoscopy and ET function testing which may include Forced Response Test (FRT), Inflation-Deflation Test (IDT) and Tubomanometry. They will also undergo evaluations for swallow, speech and soft palate function. Enrolled children will then receive instruction on the use their EMST150 exercise device. This device will be used daily for at least 2 months. Subjects will undergo full evaluations for ET function and velopharyngeal incompetence after the 2-month treatment and will then discontinue the use of devices for at least 2 months. After this time, the same testing will be done. Weekly phone calls/emails/texts from study staff will encourage use of the devices as prescribed. The following secondary outcome measures were part of the original study protocol but were eliminated after the start of the COVID-19 pandemic because the tests involved blowing maneuvers and risk of aerosolization. The protocol was modified to only include ETF tests that were necessary to achieve the goals of the study and that were safe for the participants. 'Velopharyngeal pressure after 2 months of exercise compared with baseline' 'Velopharyngeal pressure after 2 months of rest compared with baseline' 'Duration of velopharyngeal closure after 2 months of exercise compared with baseline' 'Duration of velopharyngeal closure after 2 months of rest compared with baseline' 'Ability to maintain velopharyngeal closure after 2 months of exercise compared with baseline' 'Ability to maintain velopharyngeal closure after 2 months of rest compared with baseline' 'Overall success in velopharyngeal closure after 2 months of exercise compared with baseline' 'Overall success in velopharyngeal closure following 2 months of rest compared with baseline' The following other pre-specified outcome measures were removed for the same reason: 'Velopharyngeal pressure after 2 months of rest compared with pressure immediately following 2 months of exercise' 'Duration of velopharyngeal closure after 2 months of rest compared with pressure immediately following 2 months of exercise' 'Ability to maintain velopharyngeal closure after 2 months of rest compared with ability immediately following 2 months of exercise' 'Overall success in velopharyngeal closure following 2 months of rest compared with success immediately following 2 months of exercise' 'Eustachian tube function after 2 months of rest compared with function immediately following 2 months of exercise' was moved from an other pre-specified outcome measure to a secondary outcome measure due to its similar level of importance to the other secondary outcome measures. Pressure chamber results were removed from outcome measures because they were unable to be obtained safely during the COVID-19 pandemic.
Interventions
DEVICEEMST150
The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed twice in each nostril 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Noel Jabbour
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Researchers conducing Eustachian tube function testing and those conducing statistical analysis will be blinded to the visit number.
Intervention model description
experimental, open label
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 6-17 years old * Otherwise healthy * Currently have unilateral or bilateral ventilation tube(s) (VTs) inserted for otitis media with effusion (OME) or tympanic membrane retraction/retraction pocket (TM-R/RP) or a TM perforation after extrusion of a VT * History of at least 2 sets of VT insertions in the past * Eustachian tube (ET) function (ETF) tests showing an active muscular pattern of Eustachian tube dysfunction * Some degree of velopharyngeal dysfunction during the ETF tests * Cleft Palate (CP) cohort: non-syndromic; prior palatoplasty without complications or need for revision * Non-CP cohort: have had prior adenoidectomy
Exclusion criteria
* Concurrent or past diagnosis of cancer or history of radiation * Have or had vestibular pathology, cranial base surgery or ossicular chain reconstruction * Craniofacial dysmorphology (other than non-syndromic CP with or without cleft lip in the CP cohort) or other syndrome * A non-patent nasal cavity * Patulous ET or pathologically low ET opening or closing pressures * Unable or unwilling to perform the tests and exercises outlined in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eustachian Tube Function at 2 Months | 2 months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eustachian Tube Function at 4 Months | 4 months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis |
| Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence |
| Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence |
| Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence |
| Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis |
| Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Velopharyngeal Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline | Baseline and 2 months | Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise | 2 months and 4 months | Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa |
| Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline | Baseline and 4 months | Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EMST150 Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day. | 8 |
| EMST150 Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day. | 7 |
| EMST150 + Eustachi Subjects with or without cleft palate will use the EMST150 and Eustachi 2 times a day for 8 weeks.
The Eustachi has a handle attached to a nose probe that delivers a constant airflow into the nose. The Eustachi is turned on and while one nostril is pinched with one finger, the nose probe is sealed in the other nostril. Your child will swallow 5 times and will complete an exercise diary recording whether a popping or pressure change was felt in the left, right, or both ears. This exercise sequence will be performed twice in each nostril 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.
The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day. | 3 |
| EMST150 + Eustachi Subjects with or without cleft palate will use the EMST150 and Eustachi 2 times a day for 8 weeks.
The Eustachi has a handle attached to a nose probe that delivers a constant airflow into the nose. The Eustachi is turned on and while one nostril is pinched with one finger, the nose probe is sealed in the other nostril. Your child will swallow 5 times and will complete an exercise diary recording whether a popping or pressure change was felt in the left, right, or both ears. This exercise sequence will be performed twice in each nostril 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.
The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day. | 2 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | COVID-19 Restrictions | 1 | 2 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | EMST150 + Eustachi | EMST150 | Total |
|---|---|---|---|
| Age, Continuous | 9.8 years | 10.9 years | 10.6 years |
| Age, Customized 10-12 years old | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized <10 years old | 2 Participants | 2 Participants | 4 Participants |
| Age, Customized >12 years old | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Eustachian Tube Function Deflation Test | 65.5 percent change in middle ear pressure | 5.7 percent change in middle ear pressure | 10.7 percent change in middle ear pressure |
| Eustachian Tube Function Inflation Test | 81.2 percent change in middle ear pressure | 14.9 percent change in middle ear pressure | 30.3 percent change in middle ear pressure |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 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 | 3 Participants | 7 Participants | 10 Participants |
| Region of Enrollment United States | 3 participants | 8 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 3 |
| other Total, other adverse events | 6 / 8 | 3 / 3 |
| serious Total, serious adverse events | 0 / 8 | 0 / 3 |
Outcome results
Primary
Eustachian Tube Function at 2 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
Time frame: 2 months
Population: In the EMST150 group, 2 participants were excluded because the inflation-deflation test was not able to be performed at visit 2 (due to patulous Eustachian tube or the ventilation tube being blocked). 1 participant was lost to follow-up. 3 ears with intact tympanic membranes from 3 participants were excluded~2 participants in the EMST150 + Eustachi group were excluded from analysis. 1 was lost to follow-up after visit 1 and the other was unable to complete visit 2 prior to COVID restrictions.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EMST150 | Eustachian Tube Function at 2 Months | Inflation Test | 12.0 percent change in middle ear pressure |
| EMST150 | Eustachian Tube Function at 2 Months | Deflation Test | 8.5 percent change in middle ear pressure |
| EMST150 + Eustachi | Eustachian Tube Function at 2 Months | Inflation Test | 83.6 percent change in middle ear pressure |
| EMST150 + Eustachi | Eustachian Tube Function at 2 Months | Deflation Test | 44.0 percent change in middle ear pressure |
Comparison: inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)p-value: 1Wilcoxon signed-rank
Comparison: deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)p-value: 0.734Wilcoxon signed-rank
Secondary
Eustachian Tube Function at 4 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Time frame: 4 months
Population: 4 participants completed visit 3 (all in the EMST150 group). The inflation-deflation test was not completed in 2 participants because both tympanic membranes were intact. Of the 2 other participants, testing was able to be completed for both ears for 1. The other had testing completed in 1 ear. The other ear was not tested because the tympanic membrane was intact.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EMST150 | Eustachian Tube Function at 4 Months | Inflation Test | 64.1 percent change in middle ear pressure |
| EMST150 | Eustachian Tube Function at 4 Months | Deflation Test | 6.5 percent change in middle ear pressure |
Comparison: inflation test at 4 months compared with 2 monthsp-value: 0.25Wilcoxon signed-rank
Comparison: deflation test at 4 months compared with 2 monthsp-value: 0.75Wilcoxon signed-rank
Secondary
Eustachian Tube Function at 4 Months
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Time frame: 4 months
Population: 4 participants completed visit 3 (all in the EMST150 group). The inflation-deflation test was not completed in 2 participants because both tympanic membranes were intact. Of the 2 other participants, testing was able to be completed for both ears for 1. The other had testing completed in 1 ear. The other ear was not tested because the tympanic membrane was intact.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| EMST150 | Eustachian Tube Function at 4 Months | Inflation Test | 64.1 percent change in middle ear pressure |
| EMST150 | Eustachian Tube Function at 4 Months | Deflation Test | 6.5 percent change in middle ear pressure |
Comparison: inflation test at 4 months compared with baselinep-value: 0.25Wilcoxon signed-rank
Comparison: deflation test at 4 months compared with baselinep-value: 0.75Wilcoxon signed-rank
Other Pre-specified
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 2 months
Other Pre-specified
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 4 months
Other Pre-specified
Eustachian Tube Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Maximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: 2 months and 4 months
Other Pre-specified
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Exercise Compared With Baseline
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time frame: Baseline and 2 months
Other Pre-specified
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Baseline
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time frame: Baseline and 4 months
Other Pre-specified
Perceptual Speech Symptoms of Velopharyngeal Dysfunction Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Perceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Time frame: 2 months and 4 months
Other Pre-specified
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 2 months
Other Pre-specified
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 4 months
Other Pre-specified
Residual Middle Ear Pressure Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Residual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: 2 months and 4 months
Other Pre-specified
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 2 months
Other Pre-specified
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 4 months
Other Pre-specified
Residual Nasopharyngeal Pressures Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Residual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: 2 months and 4 months
Other Pre-specified
Signs of Submucous Cleft Palate Following 2 Months of Exercise Compared With Baseline
Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis
Time frame: Baseline and 2 months
Other Pre-specified
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Baseline
Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis
Time frame: Baseline and 4 months
Other Pre-specified
Signs of Submucous Cleft Palate Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Presence or absence of dimpling anterior to the uvula, soft palate vaulting, midline groove, translucent midline, or visible notch in posterior hard palate observed on palate activation during video-analysis
Time frame: 2 months and 4 months
Other Pre-specified
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Exercise Compared With Baseline
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 2 months
Other Pre-specified
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Baseline
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: Baseline and 4 months
Other Pre-specified
Velopharyngeal Function Observed During Maneuvers Following 2 Months of Rest Compared With Immediately Following 2 Months of Exercise
Maximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Time frame: 2 months and 4 months