The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cognitive Dysfunction
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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

        1. Evaluation of body mass index (BMI): BMI was calculated according to Bray as weight (kg)
           divided by the square height (m2) and was interpreted according to the International
           Obesity Task Force (IOTF) BMI cut-offs according to the percentile of BMI adjusted for
           age and gender.

        2. Pediatric Sleep Questionnaire (PSQ) using the sleep-related breathing disorders scale
           which consists of 3 domains including 22 items with three responses to each item Yes
           (=1), No (=0), and don't know = missed answer.

        3. Neurocognitive Assessments using the NEPSY II score which is designed to assess six
           domains (Appendix 2), each domain was expressed as scaled scores with lower scores
           indicating cognitive dysfunction.

        4. Otorhinolaryngologic assessment variables:

             -  Assessment of the volume of the palatine tonsils using Brodsky grading scale
                Adenoid size was assessed by X-Ray soft tissue nasopharynx lateral view and graded
                according to. Assessment of the tongue position within the oral cavity to evaluate
                the extent of obstruction of the oral cavity by the tongue using the modified
                Mallampati method.

             -  Polysomnography (PSG) was performed according to guidelines of the American Academy
                of Sleep Medicine (AASM) for the scoring of sleep and associated events. The
                hypopnea index (HI) indicated the number of hypopneas per hour of sleep and the
                Apnea/hypopnea index (AHI) is the summation of apnea and hypopnea indices.

        5. Laboratory investigation: Venous blood samples (5 ml) were collected for ELISA
           estimation of serum levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and
           1β.

      Diagnosis and grading of OSAS

        1. Diagnosis 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.

        2. OSAS severity grading OSAS severity was graded according to the apnea-hypopnea index
           (AHI) into mild if AHI was 1-4.9, moderate if AHI 5-9.9, or severe if AHI > 10 and if
           AHI was >30 OSAS is very severe.
    

Intervention name(s): adenotonsillectomy; Lifestyle intervention
Intervention type(s): Procedure; Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment