Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 3 - 16 |
| Updated: | 4/21/2016 |
| Start Date: | February 2011 |
| End Date: | October 2013 |
In children, enlarged adenoids and/or tonsils are the most common cause of obstructive sleep
apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the
tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure
the majority of children. However, for children with only a mild degree of OSA and few
symptoms, surgery is less clear-cut, since two-thirds of these children do not develop
worsening disease.
Research shows that some children with mild OSA and behavior problems are helped by removing
the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores
on tests that measure quality of life (QOL).
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL
assessment following adenotonsillectomy. These findings may help to guide the surgeon in
selecting the children with mild OSA who are more likely to benefit from surgery.
apnea (OSA), which is temporary blockage of breathing during sleep. Surgery to remove the
tonsils and adenoids is the first-line treatment for disorder, and has been shown to cure
the majority of children. However, for children with only a mild degree of OSA and few
symptoms, surgery is less clear-cut, since two-thirds of these children do not develop
worsening disease.
Research shows that some children with mild OSA and behavior problems are helped by removing
the tonsils and adenoids. In children with all degrees of OSA, surgery has improved scores
on tests that measure quality of life (QOL).
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL
assessment following adenotonsillectomy. These findings may help to guide the surgeon in
selecting the children with mild OSA who are more likely to benefit from surgery.
Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that is characterized by
intermittent episodes of upper airway collapse and cessation of airflow during sleep. It
comprises the severest extent of a spectrum of sleep disordered breathing (SDB) which
includes primary snoring and upper airway resistance syndrome. OSA is a cause cardiovascular
morbidity in adults and children and a public health concern, affecting 2-4% of the middle
aged population (Giles 2009) and 2-3% of children in the United States (Katz 2010). It is
further associated with an increased mortality risk in adults (Giles 2009) and
well-described metabolic, cardiovascular, and neuropsychological deficits in children (Katz
2010). The latter symptoms include changes in behavior, memory and cognition, and poor
school performance.
In children, adenotonsillar hyperplasia is uniformly the most common cause of upper airway
obstruction, and the first-line therapy for these children is adenotonsillectomy (Darrow
2007). While its effectiveness is complicated by children with obesity and other
comorbidities, the most recent analyses of outcomes using postsurgical apnea-hypopnea index
reveal that adenotonsillectomy alone is able to cure approximately 60% of child OSA
(Friedman 2010). Improvements have also been shown with neuropsychological outcomes such as
behavior, school performance, attention, and others. (Katz 2010).
"Mild OSA" is an evolving definition; it is characterized by the polysomnographic finding of
AHI range greater than 1 and less than 5, defined by Katz and Marcus.(Wagner 2007) This
range corresponds to the difference in the defined pathological minimum AHI for children
(normal AHI < 1) and adults (normal AHI < 5). In practice, "mild OSA" remains a common
reason for delaying adenotonsillectomy in an otherwise asymptomatic child, since children
with mild OSA have been shown to exhibit neurocognitive functioning equivalent to
controls.(Calhoun 2009) However, psychosocially these children often have problems, and
adenotonsillectomy has been shown to improve these children's behavior as measured by
atypicality, depression, hyperactivity, and somatization.(Mitchell 2007) Furthermore, among
one-third of children with mild OSA, the natural history is progression of disease.(Li 2010)
Psychosocial problems also become manifest using health-related quality-of-life (QOL)
symptom scores. The study of QOL in children with OSA has become an area of scholarly
interest in the last 15 years. It was only in 2000 that an OSA-specific QOL questionnaire
was first developed and validated for use in children (2000 Franco). A recent meta-analysis
of QOL following adenotonsillectomy revealed significant improvements in QOL scores in
patients undergoing surgery for all severity levels of OSA.(2008 Baldassari) This
meta-analysis included studies using validated QOL instruments, namely the Child Health
Questionnaire (CHQ) and OSA-18.
Only one study of QOL in children with mild OSA found no clinically significant differences
between patients who underwent adenotonsillectomy and controls; however, disease-specific
QOL instrument (such as the OSA-18) was not used.(van Staaij 2004)
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL
assessment following adenotonsillectomy, particularly in OSA-specific domains. If true, a
threshold for preoperative QOL scores may serve as a relative indication for
adenotonsillectomy in the setting of mild OSA, independent of behavioral issues.
intermittent episodes of upper airway collapse and cessation of airflow during sleep. It
comprises the severest extent of a spectrum of sleep disordered breathing (SDB) which
includes primary snoring and upper airway resistance syndrome. OSA is a cause cardiovascular
morbidity in adults and children and a public health concern, affecting 2-4% of the middle
aged population (Giles 2009) and 2-3% of children in the United States (Katz 2010). It is
further associated with an increased mortality risk in adults (Giles 2009) and
well-described metabolic, cardiovascular, and neuropsychological deficits in children (Katz
2010). The latter symptoms include changes in behavior, memory and cognition, and poor
school performance.
In children, adenotonsillar hyperplasia is uniformly the most common cause of upper airway
obstruction, and the first-line therapy for these children is adenotonsillectomy (Darrow
2007). While its effectiveness is complicated by children with obesity and other
comorbidities, the most recent analyses of outcomes using postsurgical apnea-hypopnea index
reveal that adenotonsillectomy alone is able to cure approximately 60% of child OSA
(Friedman 2010). Improvements have also been shown with neuropsychological outcomes such as
behavior, school performance, attention, and others. (Katz 2010).
"Mild OSA" is an evolving definition; it is characterized by the polysomnographic finding of
AHI range greater than 1 and less than 5, defined by Katz and Marcus.(Wagner 2007) This
range corresponds to the difference in the defined pathological minimum AHI for children
(normal AHI < 1) and adults (normal AHI < 5). In practice, "mild OSA" remains a common
reason for delaying adenotonsillectomy in an otherwise asymptomatic child, since children
with mild OSA have been shown to exhibit neurocognitive functioning equivalent to
controls.(Calhoun 2009) However, psychosocially these children often have problems, and
adenotonsillectomy has been shown to improve these children's behavior as measured by
atypicality, depression, hyperactivity, and somatization.(Mitchell 2007) Furthermore, among
one-third of children with mild OSA, the natural history is progression of disease.(Li 2010)
Psychosocial problems also become manifest using health-related quality-of-life (QOL)
symptom scores. The study of QOL in children with OSA has become an area of scholarly
interest in the last 15 years. It was only in 2000 that an OSA-specific QOL questionnaire
was first developed and validated for use in children (2000 Franco). A recent meta-analysis
of QOL following adenotonsillectomy revealed significant improvements in QOL scores in
patients undergoing surgery for all severity levels of OSA.(2008 Baldassari) This
meta-analysis included studies using validated QOL instruments, namely the Child Health
Questionnaire (CHQ) and OSA-18.
Only one study of QOL in children with mild OSA found no clinically significant differences
between patients who underwent adenotonsillectomy and controls; however, disease-specific
QOL instrument (such as the OSA-18) was not used.(van Staaij 2004)
The investigators hypothesize that children with mild OSA will demonstrate changes on QOL
assessment following adenotonsillectomy, particularly in OSA-specific domains. If true, a
threshold for preoperative QOL scores may serve as a relative indication for
adenotonsillectomy in the setting of mild OSA, independent of behavioral issues.
Inclusion Criteria:
- Any obstructive breathing symptoms such as snoring, mouth-breathing, sleep pauses,
gasping, restless sleep, witnessed apneas, daytime somnolence, and enuresis.
- Children between the ages of 3-16 years of age that have had a sleep study with an
Apnea Hypopnea Index (AHI) score of 1 to 5.
Exclusion Criteria:
- Subject/LAR unwillingness to comply with all study procedures
- Prior otolaryngologic surgery
- Prior sleep study
- Pregnant or breastfeeding
- Under 3 years of age and older than 16 years of age
- Congenital head and neck malformations or other syndromes
We found this trial at
1
site
601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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