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View Clinical Trial (Medical Research Study)
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A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate - NCT00156442-14642 (Clinical Trial 128460)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy128460.aspx
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| City: |
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Rochester |
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State:
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NY |
| Zip Code: |
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14642 |
| Conditions: |
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Obstructive Sleep Apnea Syndrome - Cleft Lip/Palate |
| Purpose: |
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The study is to examine the relationship between sleep apnea and neurocognitive behaviors in
children with cleft lip/palate. Describe the incidence and severity of obstructive sleep
apnea in an unselected population of grade school aged children with surgically repaired
cleft palate.
A. Is the incidence of OSA higher in children with cleft palate than age matched historical
control groups? B. Are nighttime symptoms an adequate screening tool to exclude the
diagnosis of OSA in children with surgically repaired cleft palate? Describe the
velopharyngeal closure patterns during speech in an unselected population of grade school
aged children with surgically repaired cleft palate. Describe the neurobehavioral phenotype
of an unselected population of grade school aged children with surgically repaired cleft
palate.
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| Study summary: |
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Obstructive sleep apnea is closely associated with measurable, impaired cognitive function
among otherwise neurologically normal, healthy children . In addition, at least one recent
study has reported mild hyperactive-impulsive symptoms among children with sleep disordered
breathing . Cleft lip and cleft palate comprise the fourth most common birth defect
affecting 1 in 700 newborns. Despite surgical repair, nearly one in four children with
surgically repaired cleft palate will have significant velopharyngeal dysfunction .
Velopharyngeal closure is expected in nearly all sounds in the English language. As a
result, incompetence results in significant speech disability. Because hypernasal speech
patterns are more functionally disabling than hyponasality, surgeons tend to err on the side
of over-closure of the nasopharynx in an effort to improve the intelligibility of a child's
speech when performing secondary speech procedures. Thus, surgical speech procedures are
well known to result in clinically significant obstructive sleep apnea . Unfortunately, no
data exists about the impact of obstructive sleep apnea on neurocognitive function in
children with cleft palate raising the possibility that surgical intervention aimed at
improving speech may result in neurocognitive disabilities due to obstructive sleep apnea.
Furthermore, no data exists to guide surgeons as to the relative impact of poor speech
versus sleep apnea on global neurocognitive and academic functioning. We therefore
hypothesize that unrecognized obstructive sleep apnea occurs in patients with surgically
repaired cleft palate and results in demonstrable neurobehavioral sequelae. In order to
address these hypotheses, we propose the following specific aims:
Specific Aim #1:
Describe the incidence and severity of obstructive sleep apnea in an unselected population
of grade school aged children with surgically repaired cleft palate.
A. Is the incidence of OSA higher in children with cleft palate than age matched historical
control groups? B. Are nighttime symptoms an adequate screening tool to exclude the
diagnosis of OSA in children with surgically repaired cleft palate? Detailed measurement of
respiratory disturbances during sleep affecting both gas exchange and sleep state continuity
will be performed via polysomnography. Comparisons will be made between snoring and
non-snoring groups. Additional comparisons will be made with the literature where
appropriate. Although sleep disordered breathing is well known to occur with increased
frequency in children with craniofacial anomalies, the specific incidence in children with
cleft palate remains unknown. Whether snoring proves to be an adequate screening tool in
children with cleft palate also remains to be proven. We hypothesize that sleep apnea
affecting both gas exchange and sleep state continuity will be identified both in the
presence and absence of habitual snoring.
Specific Aim #2:
Describe the velopharyngeal closure patterns during speech in an unselected population of
grade school aged children with surgically repaired cleft palate. Detailed measurement of
nasal acoustic energy while reading defined passages will be performed. Measured nasalance
will be compared to assessment by a trained speech pathologist. Presence of substitutions
of consonants valved at the level of the glottis or oral pharynx, a common feature of the
misarticulations that develop when speech is acquired in the presence of velopharyngeal
dysfunction will be noted. In keeping with published literature , we hypothesize that
measured nasometry will correlate closely with speech pathologist assessment of nasality.
Furthermore, we hypothesize that misarticulations will be noted more prominently in those
children with velopharyngeal dysfunction.
Specific Aim #3:
Describe the neurobehavioral phenotype of an unselected population of grade school aged
children with surgically repaired cleft palate. Detailed assessment of neurobehavior will
be performed using the Behavior Rating Inventory of Executive Function (BRIEF), Parent &
Teacher Forms and the Conners' Parent Rating Scale-Revised/Conners' Teacher Rating Scale
(CPRS/CTRS). These questionnaires, which specifically test for executive function and
behavioral/emotional problems respectively, are selected because these are the behaviors
thought to be most affected by OSA. Comparisons will be made with normative data from the
literature where appropriate. Cleft palate carries significant long-term medical, dental,
educational and psychological burdens for those affected. We therefore hypothesize that
significant neurobehavioral abnormalities will be identified in children with surgically
repaired cleft palate |
| Criteria: |
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Inclusion Criteria:
- 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can
read and write English
Exclusion Criteria:
- Parents who cannot read and write English, children with severe neurological
compromise |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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December 29, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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