Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adenotonsillectomy
Observation alone / no intervention
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Obstructive, Child, Tonsillectomy, Adenoidectomy
Eligibility Criteria
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
Sites / Locations
- Children's Hospital of the King's Daughters
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Observation, no surgery (control)
Surgery (adenotonsillectomy)
Arm Description
Patients have been diagnosed with mild OSA, no intervention is done; enrolled patients may be randomly or nonrandomly placed in this group
Patients who have been diagnosed with mild OSA. Patient may be randomly assigned or non-randomly choose to be in this group; all undergo adenotonsillectomy
Outcomes
Primary Outcome Measures
Change in Health-related Quality of Life (HR-QOL) from baseline, as measured by the OSA-18 Questionnaire and Children's Health Questionnaire (CHQ-28)
HR-QOL forms OSA-18 and CHQ-28 to be completed by subjects at the time of enrollment, and at thereafter at three and six months. Main outcome measure is the difference or change from baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT01539278
First Posted
February 16, 2012
Last Updated
August 4, 2015
Sponsor
Eastern Virginia Medical School
Collaborators
Children's Hospital of The King's Daughters
1. Study Identification
Unique Protocol Identification Number
NCT01539278
Brief Title
Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
Official Title
Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Virginia Medical School
Collaborators
Children's Hospital of The King's Daughters
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep Apnea, Obstructive, Child, Tonsillectomy, Adenoidectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation, no surgery (control)
Arm Type
Active Comparator
Arm Description
Patients have been diagnosed with mild OSA, no intervention is done; enrolled patients may be randomly or nonrandomly placed in this group
Arm Title
Surgery (adenotonsillectomy)
Arm Type
Experimental
Arm Description
Patients who have been diagnosed with mild OSA. Patient may be randomly assigned or non-randomly choose to be in this group; all undergo adenotonsillectomy
Intervention Type
Procedure
Intervention Name(s)
Adenotonsillectomy
Other Intervention Name(s)
T&A
Intervention Description
Tonsils and adenoids are surgically removed
Intervention Type
Other
Intervention Name(s)
Observation alone / no intervention
Intervention Description
Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals
Primary Outcome Measure Information:
Title
Change in Health-related Quality of Life (HR-QOL) from baseline, as measured by the OSA-18 Questionnaire and Children's Health Questionnaire (CHQ-28)
Description
HR-QOL forms OSA-18 and CHQ-28 to be completed by subjects at the time of enrollment, and at thereafter at three and six months. Main outcome measure is the difference or change from baseline.
Time Frame
baseline, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina M. Baldassari, MD
Organizational Affiliation
Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18312869
Citation
Baldassari CM, Mitchell RB, Schubert C, Rudnick EF. Pediatric obstructive sleep apnea and quality of life: a meta-analysis. Otolaryngol Head Neck Surg. 2008 Mar;138(3):265-273. doi: 10.1016/j.otohns.2007.11.003.
Results Reference
background
PubMed Identifier
19960643
Citation
Calhoun SL, Mayes SD, Vgontzas AN, Tsaoussoglou M, Shifflett LJ, Bixler EO. No relationship between neurocognitive functioning and mild sleep disordered breathing in a community sample of children. J Clin Sleep Med. 2009 Jun 15;5(3):228-34.
Results Reference
background
PubMed Identifier
17606027
Citation
Darrow DH. Surgery for pediatric sleep apnea. Otolaryngol Clin North Am. 2007 Aug;40(4):855-75. doi: 10.1016/j.otc.2007.04.008.
Results Reference
background
PubMed Identifier
19467393
Citation
Friedman M, Wilson M, Lin HC, Chang HW. Updated systematic review of tonsillectomy and adenoidectomy for treatment of pediatric obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg. 2009 Jun;140(6):800-8. doi: 10.1016/j.otohns.2009.01.043.
Results Reference
background
PubMed Identifier
16855960
Citation
Giles TL, Lasserson TJ, Smith BH, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001106. doi: 10.1002/14651858.CD001106.pub3.
Results Reference
background
PubMed Identifier
19647481
Citation
Gozal D. Sleep, sleep disorders and inflammation in children. Sleep Med. 2009 Sep;10 Suppl 1:S12-6. doi: 10.1016/j.sleep.2009.07.003. Epub 2009 Jul 31.
Results Reference
background
PubMed Identifier
20488283
Citation
Katz ES, D'Ambrosio CM. Pediatric obstructive sleep apnea syndrome. Clin Chest Med. 2010 Jun;31(2):221-34. doi: 10.1016/j.ccm.2010.02.002.
Results Reference
background
PubMed Identifier
19776090
Citation
Li AM, Au CT, Ng SK, Abdullah VJ, Ho C, Fok TF, Ng PC, Wing YK. Natural history and predictors for progression of mild childhood obstructive sleep apnoea. Thorax. 2010 Jan;65(1):27-31. doi: 10.1136/thx.2009.120220. Epub 2009 Sep 23.
Results Reference
background
PubMed Identifier
17667138
Citation
Mitchell RB, Kelly J. Behavioral changes in children with mild sleep-disordered breathing or obstructive sleep apnea after adenotonsillectomy. Laryngoscope. 2007 Sep;117(9):1685-8. doi: 10.1097/MLG.0b013e318093edd7.
Results Reference
background
PubMed Identifier
15748193
Citation
van Staaji BK, van den Akker EH, Rovers MM, Hordijk GJ, Hoes AW, Schilder AG. Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial. Clin Otolaryngol. 2005 Feb;30(1):60-3. doi: 10.1111/j.1365-2273.2005.00980.x.
Results Reference
background
PubMed Identifier
17606021
Citation
Wagner MH, Torrez DM. Interpretation of the polysomnogram in children. Otolaryngol Clin North Am. 2007 Aug;40(4):745-59. doi: 10.1016/j.otc.2007.04.004.
Results Reference
background
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Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea
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