Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DC017553-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
End of funding
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMST150 | Experimental | Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMST150 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eustachian Tube Function at 2 Months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Eustachian Tube Function at 4 Months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 2 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Noel Jabbour, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
Individual participant data (IPD) may be shared, after de-identification, with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal.
Beginning 1 year after publication of summary data. Ending 5 years after publication.
Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Mar 3, 2023 |
Not provided
Not provided
experimental, open label
Not provided
Not provided
Researchers conducing Eustachian tube function testing and those conducing statistical analysis will be blinded to the visit number.
Not provided
|
|
| 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 |
| Baseline and 4 months |
| 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 | 2 months and 4 months |
| 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 | Baseline and 2 months |
| 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 | Baseline and 4 months |
| 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 | 2 months and 4 months |
| 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 | Baseline and 2 months |
| 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 | Baseline and 2 months |
| 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 | Baseline and 4 months |
| 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 | Baseline and 4 months |
| 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 | 2 months and 4 months |
| 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 | 2 months and 4 months |
| 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 | Baseline and 2 months |
| 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 | Baseline and 2 months |
| 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 | Baseline and 4 months |
| 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 | Baseline and 4 months |
| 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 | 2 months and 4 months |
| 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 | 2 months and 4 months |
| FG001 | 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. |
| Visit 2 |
|
| Visit 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
For Eustachian Tube Function, analysis was performed on ears from which primary outcome data were available. Data were analyzed from 7 ears from 5 participants in the EMST150 group and 2 ears from 1 participant in the EMST150 + Eustachi group.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| ears |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years | Participants |
|
| |||||||||||||||||||
| Age, Customized | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
| |||||||||||||||||||||
| Eustachian Tube Function | Percent change in middle ear pressure equilibrated during the inflation-deflation test at baseline | Eustachian tube function was analyzed for ears that had data for visit 2. | Median | Inter-Quartile Range | percent change in middle ear pressure | ears |
|
| 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 | Eustachian Tube Function at 2 Months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months | 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. | Posted | Median | Inter-Quartile Range | percent change in middle ear pressure | 2 months | ears | ears |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Eustachian Tube Function at 4 Months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months | 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. | Posted | Median | Full Range | percent change in middle ear pressure | 4 months | ears | ears |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Eustachian Tube Function at 4 Months | Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months | 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. | Posted | Median | Full Range | percent change in middle ear pressure | 4 months | ears | ears |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 2 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | Baseline and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Not Posted | 2 months and 4 months | Participants |
8 months
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 | 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. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG001 | 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. | 0 | 3 | 0 | 3 | 3 | 3 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | General disorders | Non-systematic Assessment |
| ||
| Otalgia | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Upper Respiratory Infection | General disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Discomfort or Infection | General disorders | Non-systematic Assessment |
| ||
| Patulous Eustachian Tube | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Acute Otitis Media | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| COVID-19 | General disorders | Non-systematic Assessment |
| ||
| Allergic Rhinitis Symptoms | General disorders | Non-systematic Assessment |
| ||
| Bloody Otorrhea | Ear and labyrinth disorders | Non-systematic Assessment |
|
Enrollment was limited due in part to delays related to COVID-19 restrictions. Another important limiting factor was the studied population itself. Inclusion/exclusion criteria were restrictive, and children who have persistent need for ventilation tubes frequently present with otorrhea or middle ear inflammation or tubes become blocked. These factors affect the feasibility of ETF tests and delayed study visits.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amber Shaffer | UPMC Children's Hospital of Pittsburgh | 412-692-6874 | shafferad@upmc.edu |
| Mar 30, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| D014681 | Velopharyngeal Insufficiency |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010031 | Otitis |
| D004427 | Ear Diseases |
Not provided
Not provided
| ears |
|
|
| ears |
|
|
| ears |
|
|
| ears |
|
|
| ears |
|
|
|
| Deflation Test |
|
|
| Wilcoxon signed-rank |
| 0.734 |
| Other |
| Units |
|---|
| Counts |
|---|
| Participants |
|
| ears |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| ears |
|
|
|