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Recruiting

NCT Number: NCT06283095

Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty

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

Recruiting

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

expansion palatoplasty

Procedure

surgical procedure

Primary outcomes

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

    Time frame: Six months

    Polysomngrophy

Secondary outcomes

  1. Expansion palatoplasty in Obstructive sleep apnea patients

    Time frame: Six months

    Drug induced sleep endoscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Enas T Zarief

CONTACT

[email protected]

01226270800

Mohamed O Gad

CONTACT

[email protected]

01022350318

Sponsors and collaborators

Lead sponsor

ET Zarief

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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