Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

February 21, 2024 updated by: ET Zarief
The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
we will do expansion palatoplasty
Procedure: expansion palatoplasty
surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation the outcome of expansion palatoplasty in management of OSAS.
Time Frame: Six months
Polysomngrophy
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expansion palatoplasty in Obstructive sleep apnea patients
Time Frame: Six months
Drug induced sleep endoscopy
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ET Zarief

Investigators

  • Principal Investigator: Enas T Zarief, Assuit u

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Managment of OSAS

IPD Sharing Time Frame

Three years

IPD Sharing Access Criteria

OSAS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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