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The Effectiveness of Pharyngeal Expansion Surgery Compared to Tonsil and Adenoid Removal Surgery for Treatment of Obstructive Sleep Apnea in Obese Children

The efficacy of Modified Expansion Pharyngoplasty compared to Adenotonsillectomy for treatment of OSAS in obese children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3tq6y3
Enrollment
Unknown
Registered
2018-09-24
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity sleep apnea

Interventions

Experimental group: 40 children aged 3 to 12 years, obese and with Obstructive Sleep Apnea Syndrome will undergo modified expander pharyngoplasty Control group: 40 children aged 3 to 12 years, obese
Procedure/surgery
E04.580.848
E04.580.068
E01.370.520.625

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Hospital Estadual de Ribeirão Preto
Collaborator
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: age between 3 and 12 years old; mild to severe obstructive sleep apnea in polysomnography; child obesity (BMI greater than p95)

Exclusion criteria

Exclusion criteria: Age younger than3 and older than 12 years old; syndromic patients, with craniofacial alteration or neuropsychomotor impairment, patients with asthma

Design outcomes

Primary

MeasureTime frame
Decrease in obstructive apnea andhipopnea index, verified by polysomnography, to less than or equal 1 after performing the modified expander pharyngoplasty in the study group—

Secondary

MeasureTime frame
Decrease in obstructive apnea andhipopnea index, verified by polysomnography, to less than or equal 5 after performing the modified expander pharyngoplasty in the study group—

Countries

Brazil

Contacts

Public ContactCarolina Miura

Carolina Sponchiado Miura

carolinamiura@yahoo.com.br+55-016-997524065

Outcome results

None listed

Source: REBEC (via WHO ICTRP)