Brain Tissue Integrity and Autonomic Function Alterations in Childhood OSA and ADHD, and After Adenotonsillectomy.
Attention-deficit/Hyperactivity Disorder, Autonomic Nervous System Imbalance, Obstructive Sleep Apnea of Child
About this trial
This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder focused on measuring brain magnetic resonance imaging, brain tissue integrity, heart rate variability
Eligibility Criteria
Inclusion Criteria:
- Ages 5.0 to 9.99 years at time of screening.
Diagnosis of OSA with ADHD, OSA without ADHD, or non-snoring with typical development:
2.1) Diagnosed with OSA defined as: OAI ≥1 event/h or AHI ≥2 events/h, confirmed on nocturnal, laboratory-based polysomnography and parental report of habitual snoring (on average occurring >3 nights per week).
2.2) Diagnosed with ADHD defined as: Six or more of (1) inattentive symptoms (nine symptoms), (2) hyperactive and impulsive symptoms (nine symptoms) or (3) combined inattentive, hyperactive and impulsive symptoms must be present for at least 6 months, be inconsistent with the child's developmental level, and have a negative effect on their social and academic activities.
2.3) Diagnosed with non-snoring with typical development defined as parental report of no habitual snoring (on average occurring ≤3 nights per week), <6 inattentive symptoms, <6 hyperactive and impulsive symptoms, and being consistent with the child's developmental level.
- Tonsillar hypertrophy ≥1 based on a standardized scale of 0-4 (0 = surgically absent; 1 = taking up <25% of the airway; 2 = 25-50 % of the airway; 3 = 50-75 % of the airway; 4 = >75% of the airway).
- Deemed to be a surgical candidate for adenotonsillectomy for OSA by ENT evaluation (the Part II study).
Exclusion Criteria:
- Recurrent tonsillitis that meets published ENT clinical practice guidelines for surgery defined as: > 3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year.
- Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion.
- Obstructive breathing while awake that merits prompt adenotonsillectomy in the opinion of the child's physician.
- Severe OSA or significant hypoxemia requiring immediate adenotonsillectomy as defined by: OAI >20 events/h or AHI >30 events/h or SpO2 <90% for more than 2% sleep time
- Evidence of clinically significant cardiac arrhythmia, extremely overweight (body mass index [BMI] z-score > 2.99), severe health problems that could be exacerbated by delayed treatment for OSA (such as heart disease, cor pulmonale, poorly controlled asthma, epilepsy required medication, diabetes, mental retardation), current use ADHD or psychotropic medication(s), and previous upper airway surgery.
- A family planning to move out the area within the year.
Sites / Locations
- Li-Ang LeeRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Adenotonsillectomy
Watchful waiting with supportive care
Within 1 to 4 weeks (30 days) of randomization, participants randomized to the adenotonsillectomy arm will undergo surgery under general anesthesia, as occurs as part of routine standard of care.
Within 1 to 4 weeks after the 7-month visit, participants in the Arm 2 group will be referred for re-evaluation of surgical candidacy. Symptoms and polysomnographic findings (baseline and month 7) will be reviewed by the ENT and a decision whether to proceed with adenotonsillectomy as part of routine clinical care will be made.