A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate
This study is currently recruiting patients
Verified by University of Rochester September 2006
| Sponsored by: |
University of Rochester |
| Information provided by: |
University of Rochester |
| ClinicalTrials.gov Identifier: |
NCT00156442 |
Purpose
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.
| Condition |
Obstructive Sleep Apnea Syndrome Cleft Lip/Palate |
Study Type: Observational Study Design: Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: OSAS in Children With Cleft Lip/Palate
Further study details as provided by University of Rochester:
Expected Total Enrollment:
100
Study start: September 2005
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
Eligibility
Ages Eligible for Study:
1 Year
-
18 Years,
Genders Eligible for Study:
Both
Criteria
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
Location
and Contact
Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00156442
New YorkUniversity of Rochester, Rochester,
New York,
14642,
United States; Recruiting
Margaret-Ann Carno, PhD, RN
585-273-4743
margaret_carno@urmc.rochester.edu
John Girotto, MD, Principal Investigator Heidi V. Connolly, MD, Sub-Investigator ChinTo Fong, MD, Sub-Investigator Heather Adams, PhD, Sub-Investigator Margaret-Ann Carno, PhD,RN, Sub-Investigator
Study chairs or principal investigators
John Girotto, MD, Principal Investigator, University of Rochester
Heidi V. Connolly, MD, Principal Investigator, University of Rochester
More Information
Study ID Numbers:
11595
Last Updated:
September 6, 2006
Record first received:
September 8, 2005
ClinicalTrials.gov Identifier:
NCT00156442Health Authority: United States: Institutional Review Board ClinicalTrials.gov processed this record on 2006-10-02
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