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N/A N=186 Randomized Single-blind Treatment

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

Sleep Disordered Breathing · Obstructive Sleep Apnea · Snoring · Obstructive Sleep Disordered Breathing

Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in Number of Subjects Without Oxygenation Abnormalities — 12; 10 Participants — p=0.54

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Adenotonsillectomy (AT) (Procedure)
Age
Pediatric · 4+ yrs
Sex
All
Sponsor
Chania General Hospital "St. George"
Primary completion
Apr 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Number of Subjects Without Oxygenation Abnormalities
14; 2 <0.001 sig
PRIMARY
Change in Number of Subjects Without Oxygenation Abnormalities
14; 2 <0.001 sig
SECONDARY
Symptoms Predicting Obstructive Sleep Apnea (OSA)
-0.32; -0.01 <0.001 sig
SECONDARY
Quality of Life (OSA-18 Score)
-32.4; -0.8 <0.001 sig
SECONDARY
Sleepiness
-2.75; 0.01 <0.001 sig
SECONDARY
Somatic Growth-1
23; 21 0.553
SECONDARY
Somatic Growth-2
22; 13 0.057
SECONDARY
Enuresis
10; 4 0.084
SECONDARY
Cardiovascular Effects-1
-0.1; -0.9 0.547
SECONDARY
Cardiovascular Effects-2
-1.2; -0.1 0.062
SECONDARY
Cardiovascular Effects-3
0.5; -2 0.208
SECONDARY
Cardiovascular Effects-4
-1; -6 0.585
SECONDARY
Systemic Inflammation
0; 0 0.074
SECONDARY
Improvement in Baseline SpO2
6; 7
SECONDARY
Behavioral Abnormalities-1
SECONDARY
Behavioral Abnormalities-2
SECONDARY
Effects on Sympathetic Nervous System Activation

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01918007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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