Идёт набор NCT05459935

Photobiomodulation for Pediatric Hypertrophic Tonsils

Без фазы С лечением Pediatric Sleep Apnea Obstructive Sleep Apnea Tonsils Hypertrophy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: PBM Tonsil Arm, Sham PBM Tonsil Arm.
Кому может быть актуально: Состояния в реестре: Pediatric Sleep Apnea, Obstructive Sleep Apnea, Tonsils Hypertrophy. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation

Обзор

Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea. The use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children The purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting. The investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children.

Вмешательства

Устройство PBM Tonsil Arm
exposure of hypertrophic tonsils to photobiomodulation
Устройство Sham PBM Tonsil Arm
non-powered exposure of hypertrophic tonsils to photobiomodulation

Первичные конечные точки

Tonsil Size [Срок оценки: immediately after intervention]

Вторичные конечные точки (2)

AHI Score [Срок оценки: Next Day (next night)]
Questionnaire Improvement [Срок оценки: night after, per quarter after for 1 year]

Критерии участия

Критерии включения

Brodsky visually graded tonsils 3/4
patient must assent, parent must consent, to all pre and post follow up including sleep testing
patient and parent must agree to normal referral protocols regardless of participation within this study or not