NCT06283095

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Nov 2023Nov 2026

Study Start

First participant enrolled

November 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

November 14, 2023

Last Update Submit

February 21, 2024

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

  • Evaluation the outcome of expansion palatoplasty in management of OSAS.

    Polysomngrophy

    Six months

Secondary Outcomes (1)

  • Expansion palatoplasty in Obstructive sleep apnea patients

    Six months

Study Arms (1)

study group

EXPERIMENTAL

we will do expansion palatoplasty

Procedure: expansion palatoplasty

Interventions

expansion palatoplastyPROCEDURE

surgical procedure

study group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASSUIT

Asyut, 1, Egypt

RECRUITING

Study Officials

  • Enas T Zarief

    Assuit U

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Enas T Zarief

CONTACT

01226270800enas.tharwat23@gmail.com

Mohamed O Gad

CONTACT

01022350318mohamedomar18@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 14, 2023

First Posted

February 28, 2024

Study Start

November 1, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Managment of OSAS

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Three years
Access Criteria
OSAS
More information

Locations

EG(1)