Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study
NCT ID: NCT01918007
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2013-06-30
2016-08-31
Brief Summary
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Intermittent upper airway obstruction during sleep is accompanied by low oxygen or high carbon dioxide in the blood and arousals from sleep. If obstructive SDB is not treated, complications may develop such as: i) enuresis; ii) delay in somatic growth rate; iii) central nervous system morbidity (e.g. hyperactivity and learning difficulties); and iv) elevated blood pressure.
Overnight polysomnography (PSG) is considered the gold-standard method for defining severity of obstructive SDB and subgroups of children with snoring who should be treated. However, PSG is a labor-intensive, time-consuming and expensive diagnostic method, which is not available in many community settings. Thus, there is an urgent need for developing easy-to-use and low-cost diagnostic methods which can be used to determine severity of obstructive SDB and define subgroups of children with snoring and large adenoids and tonsils who will benefit from adenotonsillectomy (AT).
Pulse oximetry is a widely available, non-invasive method which allows continuous monitoring of oxygen transport by hemoglobin. Episodes of upper airway obstruction are frequently accompanied by reductions in the hemoglobin oxygen transport (oxygen desaturation of hemoglobin).The hypothesis of this research project is that subgroups of children with snoring and adenotonsillar hypertrophy and certain abnormalities in oxygenation detected by nocturnal pulse oximetry will benefit from AT in a community setting.
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Detailed Description
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Children in the AT group will undergo the baseline study evaluation at the end of the 3-month waiting time and thus immediately prior to AT. They will also undergo the follow-up study evaluation at 3 months postoperatively.
Children in the Control group will undergo their baseline study evaluation at the time of entering the surgical waiting list. They will undergo the follow-up study evaluation 3 months later, immediately prior to AT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AT (adenotonsillectomy) Group
AT (adenotonsillectomy) immediately after the baseline study evaluation
Adenotonsillectomy (AT)
Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).
Control Group
No AT (adenotonsillectomy) for 3 months after the baseline study evaluation
No interventions assigned to this group
Interventions
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Adenotonsillectomy (AT)
Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tonsillar size \>2 \[Brodsky 1989\]
* Considered as an AT candidate during the clinic visit by ear, nose and throat (ENT) surgeon
Exclusion Criteria
* Apparent craniofacial anomalies (e.g. Crouzon syndrome or Pierre-Robin sequence)
* Obstructive breathing while awake or any other clinical signs that merit prompt AT as recommended by the treating ENT physician.
* History of clinically important cardiovascular disease or cardiac arrhythmia.
* History of: sickle cell disease; symptomatic asthma; epilepsy; use of sedative medication
* History of: genetic disorders; neurological or neuromuscular disorders
* Use of: systemic or intranasal corticosteroids; montelukast
Footnote
Brodsky score Upon inspection of the oropharynx
* grade 1 indicates that the tonsils are hidden in the pillars
* grade 2 indicates that the tonsils are beyond the anterior pillar and occupy between 25 and 50% of the pharyngeal space
* grade 3 indicates that the tonsils are beyond the pillars but not to the middle and occupy \>50% and up to 75% of the pharyngeal space
* grade 4 indicates that the tonsils occupy \>75% of the pharyngeal space
4 Years
10 Years
ALL
No
Sponsors
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Aghia Sophia Children's Hospital of Athens
OTHER
Chania General Hospital "St. George"
OTHER
Responsible Party
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Principal Investigators
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Chariton E. Papadakis, MD
Role: STUDY_DIRECTOR
Chania General Hospital "St. George"
Athanasios G. Kaditis, MD
Role: STUDY_CHAIR
Aghia Sophia Children's Hospital of Athens
Theognosia S. Chimona, MD
Role: PRINCIPAL_INVESTIGATOR
Chania General Hospital "St. George"
Panagiota N. Asimakopoulou, MD
Role: PRINCIPAL_INVESTIGATOR
Chania General Hospital "St. George"
Efklidis Proimos, MD
Role: PRINCIPAL_INVESTIGATOR
Chania General Hospital "St. George"
Konstantinos Chaidas, MD
Role: PRINCIPAL_INVESTIGATOR
Aghia Sophia Children's Hospital of Athens
Alexandra Klimentopoulou, MD
Role: PRINCIPAL_INVESTIGATOR
Aghia Sophia Children's Hospital of Athens
Locations
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Aghia Sophia Children's Hospital of Athens
Athens, , Greece
Chania General Hospital "St. George"
Chania, , Greece
Countries
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References
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Nixon GM, Kermack AS, Davis GM, Manoukian JJ, Brown KA, Brouillette RT. Planning adenotonsillectomy in children with obstructive sleep apnea: the role of overnight oximetry. Pediatrics. 2004 Jan;113(1 Pt 1):e19-25. doi: 10.1542/peds.113.1.e19.
Saito H, Araki K, Ozawa H, Mizutari K, Inagaki K, Habu N, Yamashita T, Fujii R, Miyazaki S, Ogawa K. Pulse-oximetery is useful in determining the indications for adeno-tonsillectomy in pediatric sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):1-6. doi: 10.1016/j.ijporl.2006.08.009. Epub 2006 Sep 25.
Bonuck KA, Freeman K, Henderson J. Growth and growth biomarker changes after adenotonsillectomy: systematic review and meta-analysis. Arch Dis Child. 2009 Feb;94(2):83-91. doi: 10.1136/adc.2008.141192. Epub 2008 Aug 6.
Wijga AH, Scholtens S, Wieringa MH, Kerkhof M, Gerritsen J, Brunekreef B, Smit HA. Adenotonsillectomy and the development of overweight. Pediatrics. 2009 Apr;123(4):1095-101. doi: 10.1542/peds.2008-1502.
Villa MP, Paolino MC, Castaldo R, Vanacore N, Rizzoli A, Miano S, Del Pozzo M, Montesano M. Sleep clinical record: an aid to rapid and accurate diagnosis of paediatric sleep disordered breathing. Eur Respir J. 2013 Jun;41(6):1355-61. doi: 10.1183/09031936.00215411. Epub 2012 Sep 27.
Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
Melendres MC, Lutz JM, Rubin ED, Marcus CL. Daytime sleepiness and hyperactivity in children with suspected sleep-disordered breathing. Pediatrics. 2004 Sep;114(3):768-75. doi: 10.1542/peds.2004-0730.
Alexopoulos EI, Kostadima E, Pagonari I, Zintzaras E, Gourgoulianis K, Kaditis AG. Association between primary nocturnal enuresis and habitual snoring in children. Urology. 2006 Aug;68(2):406-9. doi: 10.1016/j.urology.2006.02.021.
Franco RA Jr, Rosenfeld RM, Rao M. First place--resident clinical science award 1999. Quality of life for children with obstructive sleep apnea. Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16. doi: 10.1067/mhn.2000.105254.
Constantin E, McGregor CD, Cote V, Brouillette RT. Pulse rate and pulse rate variability decrease after adenotonsillectomy for obstructive sleep apnea. Pediatr Pulmonol. 2008 May;43(5):498-504. doi: 10.1002/ppul.20811.
Brodsky L. Modern assessment of tonsils and adenoids. Pediatr Clin North Am. 1989 Dec;36(6):1551-69. doi: 10.1016/s0031-3955(16)36806-7.
Papadakis CE, Chaidas K, Chimona TS, Zisoglou M, Ladias A, Proimos EK, Miligkos M, Kaditis AG. Assessing the need for adenotonsillectomy for sleep-disordered breathing in a community setting: A secondary outcome measures analysis of a randomized controlled study. Pediatr Pulmonol. 2019 Oct;54(10):1527-1533. doi: 10.1002/ppul.24427. Epub 2019 Jul 3.
Papadakis CE, Chaidas K, Chimona TS, Asimakopoulou P, Ladias A, Proimos EK, Miligkos M, Kaditis AG. Use of Oximetry to Determine Need for Adenotonsillectomy for Sleep-Disordered Breathing. Pediatrics. 2018 Sep;142(3):e20173382. doi: 10.1542/peds.2017-3382. Epub 2018 Aug 7.
Other Identifiers
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CHANIA-ENT-01
Identifier Type: -
Identifier Source: org_study_id
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