Status:
UNKNOWN
Brain Tissue Integrity and Autonomic Function Alterations in Childhood OSA and ADHD, and After Adenotonsillectomy.
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Conditions:
Attention-deficit/Hyperactivity Disorder
Autonomic Nervous System Imbalance
Eligibility:
All Genders
5-10 years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) and attention-deficit/hyperactivity disorder (ADHD) are two common, severe disorders in children. Unfortunately, pediatric OSA is closely associated with ADHD, and both d...
Detailed Description
Background To date, obstructive sleep apnea (OSA) is a chronic and serious disorder with an increasing prevalence in many developed countries. OSA is characterized by dynamic imbalance between airway ...
Eligibility Criteria
Inclusion
- 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:
- 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) 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.
- 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
- 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.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04732572
Start Date
August 1 2020
End Date
October 30 2023
Last Update
February 1 2021
Active Locations (1)
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1
Li-Ang Lee
Taoyuan District, Taiwan, 33305