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

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

Interventions

PROCEDURE

Adenotonsillectomy (AT)

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

Sponsors & Collaborators

• Aghia Sophia Children's Hospital of Athens

  collaborator OTHER

• Chania General Hospital "St. George"

  lead OTHER

Principal Investigators

• Chariton E. Papadakis, MD · Chania General Hospital "St. George"

• Athanasios G. Kaditis, MD · Aghia Sophia Children's Hospital of Athens

• Theognosia S. Chimona, MD · Chania General Hospital "St. George"

• Panagiota N. Asimakopoulou, MD · Chania General Hospital "St. George"

• Efklidis Proimos, MD · Chania General Hospital "St. George"

• Konstantinos Chaidas, MD · Aghia Sophia Children's Hospital of Athens

• Alexandra Klimentopoulou, MD · Aghia Sophia Children's Hospital of Athens

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

10 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2016-04-30

Completion

2016-08-31

Countries

• Greece

Study Locations