What side effects are associated with this type of intervention?

Adenotonsillectomy, the removal of adenoids and/or tonsils, is a common treatment for pediatric OSA and can lead to side effects such as pain, bleeding, infection, and, in rare cases, changes in voice or breathing difficulties. Positive airway pressure therapy, another treatment option, may cause nasal congestion, dryness, skin irritation, and discomfort from the mask. Pharmacologic treatments, though less common, can have side effects including gastrointestinal issues, dizziness, and visual disturbances. Each treatment has its own risk profile, and the choice of therapy should be tailored to the individual patient's needs and medical history.

What prior FDA approvals exist?

The primary FDA-approved treatments for Obstructive Sleep Apnea (OSA) include continuous positive airway pressure (CPAP) devices, mandibular advancement devices, and certain pharmacologic agents like dronabinol, which has shown some efficacy in reducing the apnea-hypopnea index in clinical trials. Adenotonsillectomy, the surgical removal of adenoids and/or tonsils, is a common and effective treatment for pediatric OSA, particularly when caused by adenotonsillar hypertrophy. This surgical intervention aims to alleviate airway obstruction and improve sleep quality, and while it is not a pharmacologic treatment, it remains a cornerstone in the management of OSA in children.

What other types of research exist?

Promising novel alternatives to adenotonsillectomy for treating obstructive sleep apnea (OSA) in 2024 include: 1) Transoral robot-assisted lingual tonsillectomy and uvulopalatopharyngoplasty, which addresses tongue base obstruction. 2) Radiofrequency ablation, a minimally invasive procedure that reduces tissue volume in the airway. 3) Multilevel surgery, which targets multiple sites of obstruction in the airway. These alternatives offer new approaches to managing OSA and may be considered based on individual patient needs and anatomical considerations.

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Adenotonsillectomy for Pediatric Sleep Apnea

N/A

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric OSA subjects not undergoing treatment for the breathing condition

Healthy children

Must not have

Pediatric OSA subjects with cystic fibrosis, concussion, or presence of space-occupying brain lesions

Pediatric OSA subjects with metallic or electronic implants and other MRI-specific exclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial involves children aged 7-12 with obstructive sleep apnea (OSA). The intervention is a surgery to remove the tonsils and/or adenoids to help them breathe better during sleep. Researchers will study how this surgery affects their brain, mood, and cognitive functions over time. Adenotonsillectomy is considered the first-line treatment for obstructive sleep apnea (OSA) in children, with varying effects reported in different studies.

Who is the study for?

This trial is for children aged 7-12 with moderate to severe Obstructive Sleep Apnea (OSA) who haven't had treatment yet. They'll be compared to healthy kids of the same age and body size. Kids can't join if they're obese, have had brain disorders or psychiatric diseases, cystic fibrosis, concussion, brain lesions, or any metal/electronic implants.

What is being tested?

The study tests how adenotonsillectomy (surgery to remove tonsils and/or adenoids) affects brain changes, mood, and cognition in kids with OSA. It involves two visits for OSA patients: one before surgery and another six months later; controls visit once. Both groups undergo MRI scans and questionnaires.

What are the potential side effects?

While not specified here, typical side effects of adenotonsillectomy may include pain, swelling in the throat area leading to difficulty swallowing or breathing problems temporarily after surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child has sleep apnea but isn't currently being treated for it.

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My child is healthy.

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I am a child aged 7-12 with moderate to severe sleep apnea diagnosed by a sleep study.

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I am not taking any medications for brain disorders.

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I do not have any diagnosed neurological conditions.

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I have not received treatment for my breathing condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a child with sleep apnea and have cystic fibrosis, a concussion, or a brain lesion.

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I am a child with sleep apnea and do not have any metal or electronic implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain tissue changes between baseline and after adenotonsillectomy.

Cognition assessment after adenotonsillectomy in pediatric obstructive sleep apnea patients.

Cognitive symptoms examination after adenotonsillectomy surgery.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 35 Pediatric Obstructive Sleep ApneaExperimental Treatment1 Intervention

The investigators will also determine whether brain tissue changes, reduced CBF, and altered neural responses to cognitive challenge reverse, and cognition and mood signs improve after standard surgical procedure "adenotonsillectomy" for breathing condition at 6 months in pediatric OSA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adenotonsillectomy

2014

N/A

~850

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adenotonsillectomy, the surgical removal of the adenoids and/or tonsils, is a common treatment for pediatric Obstructive Sleep Apnea (OSA). This procedure alleviates airway obstruction by removing the enlarged tissues that block the upper airway during sleep, thereby improving airflow and reducing apnea episodes. This is particularly important for OSA patients as it can lead to significant improvements in sleep quality, behavior, and overall quality of life. Additionally, it can help normalize polysomnographic (PSG) findings, which are critical for diagnosing and managing OSA. By addressing the root cause of airway obstruction, adenotonsillectomy can effectively reduce symptoms such as daytime sleepiness, inattention, and hyperactivity, which are often associated with OSA in children.