Obstructive Sleep Apnea SyndromeNCT00156442
A Study to Examine the Relationship Between Sleep Apnea and Cleft Lip/Palate
An observational study of Obstructive Sleep Apnea Syndrome and Cleft Lip/Palate, run by University of Rochester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Cleft Lip/Palate
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with celft palate and symptoms of OSA
Who may be able to join
- 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English
Who cannot join
- Parents who cannot read and write English, children with severe neurological compromise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OSAS in Children With Cleft Lip/Palate
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.
- 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.
Read the detailed description
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.
- 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
- Conditions
- Obstructive Sleep Apnea Syndrome, Cleft Lip/Palate
- Keywords
- Obstructive Sleep Apnea Syndrome, Cleft lip/palate, Children
- Medical subject headings
- Sleep Apnea, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Investigators
- John Girotto, MD, Principal investigator, University of RochesterHeidi V. Connolly, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156442
- Sponsor's protocol ID
- 11595
- Status last verified
- Sep 2006
- First submitted
- 8 Sep 2005
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSAS in Children With Cleft Lip/Palate
- ClinicalTrials.gov ID
- NCT00156442
- Acronym / sponsor ID
- 11595
- Conditions
- Obstructive Sleep Apnea Syndrome, Cleft Lip/Palate
- Keywords
- Obstructive Sleep Apnea Syndrome, Cleft lip/palate, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Detailed description
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.
- 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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with celft palate and symptoms of OSA
Key inclusion criteria (1 listed)
- 100 children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English
Key exclusion criteria (1 listed)
- Parents who cannot read and write English, children with severe neurological compromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Girotto, MD principal investigator
University of Rochester
Heidi V. Connolly, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome and Cleft Lip/Palate, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.