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TerminatedNCT03868891Updated Jun 23, 2023Results posted

Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate

An interventional study of EMST150 in Cleft Palate, Tube Disorders Eustachian and Velopharyngeal Incompetence Due to Cleft Palate, sponsored by Noel Jabbour. Terminated at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Noel Jabbour · Not applicable, Interventional, and Treatment

Why this study was terminated
End of funding
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cleft Palate
  • Tube Disorders Eustachian
  • Velopharyngeal Incompetence Due to Cleft Palate
  • Velopharyngeal Insufficiency

Keywords

  • Otitis media
  • Eustachian tube
  • Eustachian tube dysfunction
  • Eustachian tube function testing
  • Middle ear ventilation
03

In context

Cleft Palate

131 studies on the registry are indexed under Cleft Palate; 36 are open to participants now.

This study's enrollment of 11 is below the median of 40 across 85 interventional studies indexed under Cleft Palate.

Browse Cleft Palate studies →

Lead sponsor

Noel Jabbour is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    EMST150

    Subjects with or without cleft palate will use the EMST150 2 times a day for 8 weeks.

    Device: EMST150

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.

    Also known as: Expiratory Muscle Strength Trainer 150

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

07

Results

Posted Jun 23, 2023
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneEMST150EMST150 + Eustachi
Started83
Visit 271
Visit 340
Completed40
Not completed43
Withdrew: Adverse event10
Withdrew: Lost to follow-up21
Withdrew: Covid-19 restrictions12

Outcome measures

PrimaryEustachian Tube Function at 2 Months

Percent change in middle ear pressure equilibrated during the inflation-deflation test at 2 months

Time frame:
2 months
Reported as:
Median · percent change in middle ear pressure
Eustachian Tube Function at 2 Months
percent change in middle ear pressureEMST150EMST150 + Eustachi
Inflation Test12.0 (10.4 to 65.8)83.6 (77.5 to 89.7)
Deflation Test8.5 (4.7 to 10.4)44.0 (33.2 to 54.8)
Statistical analysis
  • EMST150 · Wilcoxon signed-rank · p = 1.00
  • EMST150 · Wilcoxon signed-rank · p = 0.734
SecondaryEustachian Tube Function at 4 Months

Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months

Time frame:
4 months
Reported as:
Median · percent change in middle ear pressure
Eustachian Tube Function at 4 Months
percent change in middle ear pressureEMST150
Inflation Test64.1 (23.0 to 87.2)
Deflation Test6.5 (6.0 to 9.9)
Statistical analysis
  • EMST150 · Wilcoxon signed-rank · p = 0.25
  • EMST150 · Wilcoxon signed-rank · p = 0.75
SecondaryEustachian Tube Function at 4 Months

Percent change in middle ear pressure equilibrated during the inflation-deflation test at 4 months

Time frame:
4 months
Reported as:
Median · percent change in middle ear pressure
Eustachian Tube Function at 4 Months
percent change in middle ear pressureEMST150
Inflation Test64.1 (23.0 to 87.2)
Deflation Test6.5 (6.0 to 9.9)
Statistical analysis
  • EMST150 · Wilcoxon signed-rank · p = 0.25
  • EMST150 · Wilcoxon signed-rank · p = 0.75
Other pre-specifiedSigns 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

Results for this outcome have not been posted.

Other pre-specifiedSigns 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

Results for this outcome have not been posted.

Other pre-specifiedSigns 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

Results for this outcome have not been posted.

Other pre-specifiedPerceptual 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

Results for this outcome have not been posted.

Other pre-specifiedPerceptual 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

Results for this outcome have not been posted.

Other pre-specifiedPerceptual 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

Results for this outcome have not been posted.

Other pre-specifiedEustachian 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Other pre-specifiedEustachian 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Other pre-specifiedEustachian 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Other pre-specifiedVelopharyngeal 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Other pre-specifiedVelopharyngeal 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Other pre-specifiedVelopharyngeal 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

Results for this outcome have not been posted.

Other pre-specifiedResidual 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

Results for this outcome have not been posted.

Adverse events

Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EMST1500/8 (0%)0/8 (0%)6/8 (75%)
EMST150 + Eustachi0/3 (0%)0/3 (0%)3/3 (100%)
Most frequent other events
Most frequent other events
EventEMST150EMST150 + Eustachi
Upper Respiratory InfectionGeneral disorders4/83/3
EpistaxisGeneral disorders1/82/3
OtalgiaEar and labyrinth disorders1/82/3
Gastrointestinal Discomfort or InfectionGeneral disorders0/82/3
Patulous Eustachian TubeEar and labyrinth disorders1/80/3
Acute Otitis MediaEar and labyrinth disorders1/80/3
COVID-19General disorders1/80/3
Allergic Rhinitis SymptomsGeneral disorders1/80/3
Bloody OtorrheaEar and labyrinth disorders1/80/3

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)EMST150EMST150 + EustachiTotal
Median10.9 (9.9 to 14.8)9.8 (9.7 to 15.2)10.6 (9.7 to 15.2)
Age, Customized
Age, Customized(Participants)EMST150EMST150 + EustachiTotal
<10 years old224
10-12 years old303
>12 years old314
Sex: Female, Male
Sex: Female, Male(Participants)EMST150EMST150 + EustachiTotal
Female538
Male303
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)EMST150EMST150 + EustachiTotal
Hispanic or Latino000
Not Hispanic or Latino7310
Unknown or Not Reported101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EMST150EMST150 + EustachiTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White7310
More than one race101
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)EMST150EMST150 + EustachiTotal
United States8311
Eustachian Tube Function
Eustachian Tube Function(percent change in middle ear pressure)EMST150EMST150 + EustachiTotal
Inflation Test14.9 (9.6 to 50.8)81.2 (75.1 to 87.3)30.3 (14.8 to 67.5)
Deflation Test5.7 (4.0 to 17.9)65.5 (30.5 to 100.5)10.7 (4.7 to 21.0)
08

Study locations

1 site
  • UPMC Children's Hospital of Pittsburgh
    Pittsburgh, Pennsylvania 15224, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 3, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03868891
Lead sponsor
Noel Jabbour
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Responsible party
Noel Jabbour (Assistant Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Mar 11, 2019
Start date
Aug 16, 2019
Primary completion
Apr 6, 2022
Completion
May 31, 2022
Results posted
Jun 23, 2023
Last update
Jun 23, 2023

Study contacts

Noel Jabbour, MD, MS
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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