Trial record 3 of 714 for:    "Sleep Apnea, Obstructive"

Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Eastern Virginia Medical School
Sponsor:
Collaborator:
Children's Hospital of The King's Daughters
Information provided by (Responsible Party):
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01539278
First received: February 16, 2012
Last updated: January 13, 2014
Last verified: February 2012
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Procedure: Adenotonsillectomy
Other: Observation alone / no intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Adenotonsillectomy on Quality of Life in Children With Mild Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Eastern Virginia Medical School:

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) [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Observation, no surgery (control)
Patients have been diagnosed with mild OSA, no intervention is done; enrolled patients may be randomly or nonrandomly placed in this group
Other: Observation alone / no intervention
Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals
Experimental: Surgery (adenotonsillectomy)
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
Procedure: Adenotonsillectomy
Tonsils and adenoids are surgically removed
Other Name: T&A

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.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539278

Contacts
Contact: Cristina M. Baldassari, MD 757-668-9327 cristina.baldassari@chkd.org
Contact: Peter G. Volsky, MD 757-388-6200 volskypg@evms.edu

Locations
United States, Virginia
Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Principal Investigator: Cristina M. Baldassari, MD         
Sub-Investigator: Peter G. Volsky, MD         
Sponsors and Collaborators
Eastern Virginia Medical School
Children's Hospital of The King's Daughters
Investigators
Principal Investigator: Cristina M. Baldassari, MD Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters
  More Information

Publications:

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01539278     History of Changes
Other Study ID Numbers: 10-12-FB-0266
Study First Received: February 16, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Eastern Virginia Medical School:
Sleep Apnea, Obstructive
Child
Tonsillectomy
Adenoidectomy

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014