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The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients

NCT05421403 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-06-16

No results posted yet for this study

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

Conditions

Interventions

PROCEDURE

adenotonsillectomy

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

BEHAVIORAL

Lifestyle intervention

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.

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-07
Primary Completion
2021-03-01
Completion
2021-06-15

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421403 on ClinicalTrials.gov