Al-Azhar University
Asyut, Egypt
NCT Number: NCT05421403
Objectives: Determination of the impact of obstructive sleep apnea (OSA) on the cognitive function (CF) and serum tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and 1β levels in children aged 5-12 years and the effect of OSA management on these variables.
Patients & Methods: 224 patients were evaluated using the Pediatric Sleep Questionnaire, the NEPSY score for CF and Polysomnography (PSG) to grade OSA severity according to the Apnea/hypopnea index (AHI). Patients with adenotonsillar hypertrophy grade >2 will undergo the appropriate surgical intervention. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI). Blood samples were obtained for ELISA estimation of cytokines' levels. At end of 6-m follow-up, all variables were re-evaluated
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Notify Me5 year–12 year
All sexes
Interventional
Not applicable
Asyut, Egypt
All children aged 5-12 years who attended the outpatient clinics of Otorhinolaryngology and/or Pediatrics with complaints suggestive of OSAS were eligible for evaluation for exclusion and inclusion criteria according to the conditions of the Local Ethical Committee which approved the study protocol by number.
Evaluation Tools
Diagnosis and grading of OSAS
Pediatric OSAS was diagnosed according to guidelines of the American Academy of Sleep Medicine (21) depending on both the clinical findings and the polysomnographic criteria for diagnosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
all patients with adenoid or tonsillar or adenotonsillar hypertrophy of grade >2 will undergo adenoidectomy, tonsillectomy or adenotonsillectomy (AT) according to the indication. Overweight or obese patients with mild or moderate OSAS will undergo 6-m trial of lifestyle intervention (LSI) and CPAP if indicated, responders will undergo more follow-up otherwise surgical interference was indicated
After baseline testing, all subjects began a structured 6-month LSI consisting of dietary modification and exercise. Intensive dietary counseling was provided weekly for the first 4 weeks of the intervention, monthly subsequently until 6 months. A target caloric deficit of ~250.500 cal/d was recommended throughout dietary counseling. Dietary regimen consisted of diets composed of nutrients contributing to total energy as 55% carbohydrate, 15% protein, and 30% fat. Other lifestyle changes included calorie restriction depending on reduction of the frequency of snack consumption, ingestion of low-calorie and low-fat snacks, limiting sugar-based carbonated drinks and the duration of television watching or mobile games. Exercise sessions consisted of both aerobic and strength training three times weekly.
Time frame: 6 months
The effect of relieve of obstruction on sleep-related breathing disorders and cognitive function as judged by the Pediatric Sleep Questionnaire at end of follow up
Time frame: 6 months
The effect of relieve of obstruction and weight reduction on sleep-related breathing disorders as judged by the NESPY score at end of follow up
Al-Azhar University
Other
The Interplay Between Obstructive Sleep Apnea and Inflammatory Cytokines Induces Cognitive Dysfunction in Pediatric Patients
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