Trial Outcomes & Findings for Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate (NCT NCT03868891)
NCT ID: NCT03868891
Last Updated: 2023-06-23
Results Overview
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
2 months
Results posted on
2023-06-23
Participant Flow
Participant milestones
| Measure |
EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
EMST150: 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.
|
EMST150 + Eustachi
Eustachi: 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.
EMST150: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
Visit 2
|
7
|
1
|
|
Overall Study
Visit 3
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
EMST150
Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.
EMST150: 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.
|
EMST150 + Eustachi
Eustachi: 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.
EMST150: 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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
COVID-19 Restrictions
|
1
|
2
|
Baseline Characteristics
Eustachian tube function was analyzed for ears that had data for visit 2.
Baseline characteristics by cohort
| Measure |
EMST150
n=7 ears
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.
|
EMST150 + Eustachi
n=2 ears
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.
|
Total
n=9 ears
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.9 years
n=8 Participants
|
9.8 years
n=3 Participants
|
10.6 years
n=11 Participants
|
|
Age, Customized
<10 years old
|
2 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=11 Participants
|
|
Age, Customized
10-12 years old
|
3 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=11 Participants
|
|
Age, Customized
>12 years old
|
3 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=11 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=11 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=11 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=11 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
3 participants
n=3 Participants
|
11 participants
n=11 Participants
|
|
Eustachian Tube Function
Inflation Test
|
14.9 percent change in middle ear pressure
n=7 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
81.2 percent change in middle ear pressure
n=2 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
30.3 percent change in middle ear pressure
n=9 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
|
Eustachian Tube Function
Deflation Test
|
5.7 percent change in middle ear pressure
n=7 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
65.5 percent change in middle ear pressure
n=2 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
10.7 percent change in middle ear pressure
n=9 ears • Eustachian tube function was analyzed for ears that had data for visit 2.
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: 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.
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months
Outcome measures
| Measure |
EMST150
n=7 ears
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.
|
EMST150 + Eustachi
n=2 ears
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.
|
|---|---|---|
|
Eustachian Tube Function at 2 Months
Inflation Test
|
12.0 percent change in middle ear pressure
Interval 10.4 to 65.8
|
83.6 percent change in middle ear pressure
Interval 77.5 to 89.7
|
|
Eustachian Tube Function at 2 Months
Deflation Test
|
8.5 percent change in middle ear pressure
Interval 4.7 to 10.4
|
44.0 percent change in middle ear pressure
Interval 33.2 to 54.8
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Outcome measures
| Measure |
EMST150
n=3 ears
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.
|
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.
|
|---|---|---|
|
Eustachian Tube Function at 4 Months
Inflation Test
|
64.1 percent change in middle ear pressure
Interval 23.0 to 87.2
|
—
|
|
Eustachian Tube Function at 4 Months
Deflation Test
|
6.5 percent change in middle ear pressure
Interval 6.0 to 9.9
|
—
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months
Outcome measures
| Measure |
EMST150
n=3 ears
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.
|
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.
|
|---|---|---|
|
Eustachian Tube Function at 4 Months
Inflation Test
|
64.1 percent change in middle ear pressure
Interval 23.0 to 87.2
|
—
|
|
Eustachian Tube Function at 4 Months
Deflation Test
|
6.5 percent change in middle ear pressure
Interval 6.0 to 9.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPresence 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsPresence 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsPresence 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsPerceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsPerceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsPerceptual symptoms of velopharyngeal incompetence measured using the Pittsburgh Weighted Speech Score, on a scale of 0-23, with ≥7 indicating likely velopharyngeal incompetence
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsMaximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsResidual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsMaximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsResidual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsMaximum middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsResidual middle ear pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsMaximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 2 monthsResidual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsMaximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 4 monthsResidual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsMaximum nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 months and 4 monthsResidual nasopharyngeal pressures achieved during Toynbee, Valsalva, Sniffing, Dive maneuver and the Patulous Test in daPa
Outcome measures
Outcome data not reported
Adverse Events
EMST150
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
EMST150 + Eustachi
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EMST150
n=8 participants at risk
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.
|
EMST150 + Eustachi
n=3 participants at risk
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.
|
|---|---|---|
|
General disorders
Epistaxis
|
12.5%
1/8 • Number of events 2 • 8 months
|
66.7%
2/3 • Number of events 2 • 8 months
|
|
Ear and labyrinth disorders
Otalgia
|
12.5%
1/8 • Number of events 1 • 8 months
|
66.7%
2/3 • Number of events 2 • 8 months
|
|
General disorders
Upper Respiratory Infection
|
50.0%
4/8 • Number of events 4 • 8 months
|
100.0%
3/3 • Number of events 7 • 8 months
|
|
General disorders
Gastrointestinal Discomfort or Infection
|
0.00%
0/8 • 8 months
|
66.7%
2/3 • Number of events 3 • 8 months
|
|
Ear and labyrinth disorders
Patulous Eustachian Tube
|
12.5%
1/8 • Number of events 1 • 8 months
|
0.00%
0/3 • 8 months
|
|
Ear and labyrinth disorders
Acute Otitis Media
|
12.5%
1/8 • Number of events 1 • 8 months
|
0.00%
0/3 • 8 months
|
|
General disorders
COVID-19
|
12.5%
1/8 • Number of events 1 • 8 months
|
0.00%
0/3 • 8 months
|
|
General disorders
Allergic Rhinitis Symptoms
|
12.5%
1/8 • Number of events 2 • 8 months
|
0.00%
0/3 • 8 months
|
|
Ear and labyrinth disorders
Bloody Otorrhea
|
12.5%
1/8 • Number of events 3 • 8 months
|
0.00%
0/3 • 8 months
|
Additional Information
Dr. Amber Shaffer
UPMC Children's Hospital of Pittsburgh
Phone: 412-692-6874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place