NCT01539278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

February 16, 2012

Last Update Submit

August 4, 2015

Conditions

Sleep Apnea, Obstructive

Keywords

Sleep Apnea, ObstructiveChildTonsillectomyAdenoidectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 3 months, 6 months

Study Arms (2)

Observation, no surgery (control)

ACTIVE COMPARATOR

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

Surgery (adenotonsillectomy)

EXPERIMENTAL

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

Interventions

AdenotonsillectomyPROCEDURE

Tonsils and adenoids are surgically removed

Also known as: T&A
Surgery (adenotonsillectomy)
Observation alone / no interventionOTHER

Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals

Observation, no surgery (control)

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (11)

  • 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.

    PMID: 18312869BACKGROUND

  • 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.

    PMID: 19960643BACKGROUND

  • 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.

    PMID: 17606027BACKGROUND

  • 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.

    PMID: 19467393BACKGROUND

  • 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;2006(3):CD001106. doi: 10.1002/14651858.CD001106.pub3.

    PMID: 16855960BACKGROUND

  • 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.

    PMID: 19647481BACKGROUND

  • 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.

    PMID: 20488283BACKGROUND

  • 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.

    PMID: 19776090BACKGROUND

  • 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.

    PMID: 17667138BACKGROUND

  • 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.

    PMID: 15748193BACKGROUND

  • 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.

    PMID: 17606021BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Observation

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Cristina M. Baldassari, MD

    Eastern Virginia Medical School Dept. of Otolaryngology-Head & Neck Surgery; Children's Hospital of the King's Daughters

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 27, 2012

Study Start

February 1, 2011

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

US(1)