Adenotonsillectomy for Obstructive Sleep-Disordered Breathing in Childhood:The Chania Community Oximetry-Based Study
Condition: Sleep Disordered Breathing; Obstructive Sleep Apnea; Snoring; Obstructive Sleep Disordered Breathing
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Snoring
Study type: Interventional

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.
    

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 and randomized in the Active Comparator (AT group) or in the Control Group (No
      AT group) at the time of the initial clinic visit, if they fulfill the Inclusion Criteria and
      their parents consent to participation in the study.

      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.
    

Intervention name(s): Adenotonsillectomy (AT)
Intervention type(s): Procedure
Intervention description(s): Standard surgical intervention for treatment of obstructive sleep-disordered (SDB).
Other intervention name(s): Removal of adenoids and tonsils
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
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