Recruiting NCT06283095
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: expansion palatoplasty.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea of Adult. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure expansion palatoplasty
surgical procedure
Primary outcome measures
- Evaluation the outcome of expansion palatoplasty in management of OSAS. [Time frame: Six months]
Secondary outcome measures (1)
- Expansion palatoplasty in Obstructive sleep apnea patients [Time frame: Six months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- ASSUIT — Asyut
Identifiers
NCT: NCT06283095 · OSA