Management of Obstructive Sleep Apnea Syndrome by Expansi... | NCT06283095

Studies
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

NCT06283095

Sponsor

ET Zarief

Status

Recruiting

Last Update Posted

Feb 28, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea of Adult

Interventions

expansion palatoplasty

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Feb 21, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	we will do expansion palatoplasty	Procedure: expansion palatoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
expansion palatoplasty	Procedure	surgical procedure	study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Enas T Zarief	Contact	01226270800		enas.tharwat23@gmail.com
Mohamed O Gad	Contact	01022350318		mohamedomar18@yahoo.com

Overall Officials

Name	Affiliation	Role
Enas T Zarief	Assuit U	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASSUIT	Recruiting	Asyut		1	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Managment of OSAS

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Three years

Access Criteria

OSAS

URL

http://enas.tharwat23@gmail.com