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NCT06283095 Clinical Trial

Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06283095
Other study ID # OSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date November 1, 2026

Study information
Verified date February 2024
Source Assiut University
Contact Enas T Zarief
Phone 01226270800
Email enas.tharwat23@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS.

Description:

Expansion palatopladty will be conducted on patients with obstructive sleep apnea patients to evaluate the outcome.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 1, 2026
Est. primary completion date November 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Adult patients. - Body mass index < 30 kg/m2 (weight /height in m2) - Mild to moderate OSAS - Sagittal collapse of the lateral pharyngeal walls proved by Drug induced sleep endoscopy (DISE). Exclusion Criteria: - • Refusing enrollment into the study. - Pregnant women. - Refusing the surgery - Contraindication to anaesthesia - Patients with multilevel of obstruction. - Serious psychiatric, neurological and cardiopulmonary (COPD or corpulmonale) diseases. - Uncorrected hypothyroidism. - Severe OSAS. - Craniofacial anamolies. - Central& mixed apnea - Morbid obesity.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• expansion palatoplasty
surgical procedure

Locations
Country Name City State
Egypt ASSUIT Assuit

Sponsors (1)
Lead Sponsor Collaborator
ET Zarief

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation the outcome of expansion palatoplasty in management of OSAS. Polysomngrophy Six months
Secondary Expansion palatoplasty in Obstructive sleep apnea patients Drug induced sleep endoscopy Six months
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