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

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

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

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.

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.

Sleep Disordered Breathing, Obstructive Sleep Apnea, Adenotonsillectomy, Snoring, Obstructive Sleep Disordered Breathing

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

Change in proportion 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.

Proportion 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)

Percent of subjects achieving an increase in weight z-score or in body mass index z-score of at least 0.5.

Change in the Sleep Clinical Record score and change in Pediatric Sleep Questionnaire score, between follow-up and baseline.

Percent of subjects who achieved frequency of nocturnal enuresis < 1 night per week at follow-up (3 months), if they had incontinence at least 1 night per week at baseline (0 months).

Change in morning urine norepinephrine-corrected for urine creatinine- between follow-up and baseline.

Proportion of subjects who had an increase from baseline in SpO2 of >1.6% according to baseline SpO2 level

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

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