Status:
COMPLETED
Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study
Lead Sponsor:
Chania General Hospital "St. George"
Collaborating Sponsors:
Aghia Sophia Children's Hospital of Athens
Conditions:
Sleep Disordered Breathing
Obstructive Sleep Apnea
Eligibility:
All Genders
4-10 years
Phase:
NA
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...
Detailed Description
Time in the waiting list for undergoing AT at the Department of Otorhinolaryngology, Chania General Hospital "St. George" is approximately 3 months. In the present study, children will be recruited an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT01918007
Start Date
June 1 2013
End Date
August 1 2016
Last Update
November 13 2023
Active Locations (2)
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1
Aghia Sophia Children's Hospital of Athens
Athens, Greece, 11527
2
Chania General Hospital "St. George"
Chania, Greece, 73300