The Interplay Between Obstructive Sleep Apnea Cognitive Dysfunction in Pediatric Patients

NCT05421403 | Completed

• 1 other identifier: AUAREC20190509-12
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Relive of OSAS

  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

  6 months

• Effect of weight reduction on sleep-related breathing disorders

  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

  6 months

Study Arms (2)

Surgical

ACTIVE COMPARATOR

Procedure: adenotonsillectomy

non-Surgical

PLACEBO COMPARATOR

Behavioral: Lifestyle intervention

Interventions

adenotonsillectomy PROCEDURE

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

Surgical

Lifestyle intervention BEHAVIORAL

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.

non-Surgical

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• The presence of craniofacial anomalies
• neurological disorders
• very severe OSAS
• OSAS complicated by complex comorbidities
• residual OSAS following adenotonsillectomy (AT), hypothyroidism, or refusal of the suggested therapeutic plans.
• children who failed or were unable to undergo the cognitive function evaluation and those whose parents refused to undergo polysomnography were also excluded from the study.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Asyut, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of ENT

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 16, 2022
• Study Start: November 7, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 15, 2021
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

EG (1)