Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

NCT ID: NCT06283095

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-11-01

Brief Summary

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

Detailed Description

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

Conditions

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

we will do expansion palatoplasty

Group Type EXPERIMENTAL

expansion palatoplasty

Intervention Type PROCEDURE

surgical procedure

Interventions

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expansion palatoplasty

surgical procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ET Zarief

OTHER

Sponsor Role lead

Responsible Party

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ET Zarief

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enas T Zarief

Role: PRINCIPAL_INVESTIGATOR

Assuit U

Locations

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ASSUIT

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Enas T Zarief

Role: CONTACT

01226270800

Mohamed O Gad

Role: CONTACT

01022350318

Facility Contacts

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Enas T Zarief, physician

Role: primary

01226270800

Other Identifiers

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OSA

Identifier Type: -

Identifier Source: org_study_id

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