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Middle Ear Pressure Disregulation in Cleft Palate Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423072
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : February 18, 2019
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Cuneyt M. Alper, University of Pittsburgh

Brief Summary:
The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.

Condition or disease
Cleft Palate

Detailed Description:
Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Middle Ear Pressure Disregulation in Cleft Palate Patients: Form-Function Correlates
Study Start Date : August 2006
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

children with cleft palate birth-24 months of age

Primary Outcome Measures :
  1. otitis media [ Time Frame: 5 years ]
    status of middle ear at 5 years of age

Secondary Outcome Measures :
  1. anatomic variables [ Time Frame: 3 and 5 years ]
    MRI data at 3 and 5 years in subset; cephalometric x-rays at 6 yr.

  2. Eustachian tube function testing [ Time Frame: pre- and post palatoplasty, yearly to age 18 yrs ]
    either Forced Response testing or pressure chamber testing

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with cleft palate <2 years of age

Inclusion Criteria:

  • birth-24 months
  • unrepaired or recently repaired cleft palate

Exclusion Criteria:

  • cleft palate associated with syndrome
  • known immune deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423072

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United States, Pennsylvania
ENT Research Center Childrens' Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Deafness and Other Communication Disorders (NIDCD)
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Principal Investigator: Cuneyt M Alper, MD University of Pittsburgh
Publications of Results:
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Responsible Party: Cuneyt M. Alper, Professor, Otolaryngology, University of Pittsburgh Identifier: NCT00423072    
Other Study ID Numbers: 0607009
1P50DC007667 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cuneyt M. Alper, University of Pittsburgh:
cleft palate
middle ear
Eustachian tube
Additional relevant MeSH terms:
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Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities