Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study

NCT01918007 | Completed Results

• 1 other identifier: CHANIA-ENT-01
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

Brief Summary

Obstructive sleep-disordered breathing (SDB) in childhood is a disorder of breathing during sleep characterized by intermittent upper airway obstruction. Snoring, labored breathing and apneas reported by the parents are the most frequent symptoms.Obstructive SDB can result from many different abnormalities including large adenoids and tonsils or obesity. 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.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea; Snoring; Obstructive Sleep Disordered Breathing

Keywords

Apnea; Sleep Apnea Syndromes; Snoring; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Disorders; Respiratory Sounds

Outcome Measures

Primary Outcomes (2)

• Change in Number of Subjects Without Oxygenation Abnormalities

  Change in number of participants with a McGill oximetry score =1 (usual oxygen saturation of hemoglobin-SpO2\>95%; fewer than 3 drops below 90%; and fewer than 3 clusters of desaturation events) between 3 months and 0 months. McGill oximetry score=1: normal or inconclusive nocturnal oximetry; McGill oximetry score=2: mild hypoxemia; McGill oximetry score=3: moderate hypoxemia; McGill oximetry score=4: severe hypoxemia.

  3 months (follow-up), 0 months (baseline)

• Change in Number of Subjects Without Oxygenation Abnormalities

  Number of subjects who achieved a desaturation index (≥3% drop) of \<2 episodes/h at 3 months (follow-up), if they had a desaturation index of ≥ 3.5 episodes/h at 0 months (baseline)

  3 months (follow-up), 0 months (baseline)

Secondary Outcomes (15)

• Symptoms Predicting Obstructive Sleep Apnea (OSA)

  3 months (follow-up), 0 months (baseline)

• Quality of Life (OSA-18 Score)

  3 months (follow-up), 0 months (baseline)

• Sleepiness

  3 months (follow-up), 0 months (baseline)

• Somatic Growth-1

  0 months (baseline), 3 months (follow-up)

• Somatic Growth-2

  0 months (baseline), 3 months (follow-up)

Study Arms (2)

AT (adenotonsillectomy) Group

ACTIVE COMPARATOR

AT (adenotonsillectomy) immediately after the baseline study evaluation

Procedure: Adenotonsillectomy (AT)

Control Group

NO INTERVENTION

No AT (adenotonsillectomy) for 3 months after the baseline study evaluation

Interventions

Adenotonsillectomy (AT) PROCEDURE

Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).

Also known as: Removal of adenoids and tonsils

AT (adenotonsillectomy) Group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with obstructive SDB (snoring \>3 nights/week over the last 6 months)
• Tonsillar size \>2 \[Brodsky 1989\]
• Considered as an AT candidate during the clinic visit by ear, nose and throat (ENT) surgeon

You may not qualify if:

• Recurrent tonsillitis defined as at least 3 episodes in each of the last 3 years or at least 5 episodes in each of the last 2 years or at least 7 episodes in the past year.
• 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

Sponsors & Collaborators

• Chania General Hospital "St. George": lead
• Aghia Sophia Children's Hospital of Athens: collaborator

Study Sites (2)

Aghia Sophia Children's Hospital of Athens

Athens, 11527, Greece

Location

Chania General Hospital "St. George"

Chania, 73300, Greece

Location

Related Publications (13)

• 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.

  PMID: 14702490 BACKGROUND

• 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.

  PMID: 16997385 BACKGROUND

• 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.

  PMID: 18684748 BACKGROUND

• 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.

  PMID: 19336367 BACKGROUND

• 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.

  PMID: 23018902 BACKGROUND

• 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.

  PMID: 10733617 BACKGROUND

• 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.

  PMID: 15342852 BACKGROUND

• 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.

  PMID: 16904463 BACKGROUND

• 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.

  PMID: 10889473 BACKGROUND

• 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.

  PMID: 18383115 BACKGROUND

• 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.

  PMID: 2685730 BACKGROUND

• 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.

  PMID: 31270970 DERIVED

• 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.

  PMID: 30087199 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring; Apnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Respiratory Sounds

Interventions

Adenoidectomy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Oximetry was performed in-hospital and not at patients' homes.

Results Point of Contact

• Title: Dr. Athanasios Kaditis, Head, Division of Pediatric Pulmonology, First Department of Pediatrics
• Organization: National and Kapodistrian University of Athens School of Medicine and Aghia Sophia Children's Hospital, Athens, Greece

akaditis@med.uoa.gr

+302132013000

Study Officials

• Chariton E. Papadakis, MD

  Chania General Hospital "St. George"

  STUDY DIRECTOR

• Athanasios G. Kaditis, MD

  Aghia Sophia Children's Hospital of Athens

  STUDY CHAIR

• Theognosia S. Chimona, MD

  Chania General Hospital "St. George"

  PRINCIPAL INVESTIGATOR

• Panagiota N. Asimakopoulou, MD

  Chania General Hospital "St. George"

  PRINCIPAL INVESTIGATOR

• Efklidis Proimos, MD

  Chania General Hospital "St. George"

  PRINCIPAL INVESTIGATOR

• Konstantinos Chaidas, MD

  Aghia Sophia Children's Hospital of Athens

  PRINCIPAL INVESTIGATOR

• Alexandra Klimentopoulou, MD

  Aghia Sophia Children's Hospital of Athens

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 7, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2020-08

Locations

GR (2)