Modified anterior palatoplasty for obstructive sleep apnea
Barbed Suture Modified Anterior Palatoplasty In Management of Mild and Moderate Obstructive Sleep Apnea Syndrome
This study tests a new surgical technique to see if it can help people with mild to moderate obstructive sleep apnea sleep better after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Qalyubia Governorate) |
| Trial ID | NCT04572503 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a modified surgical technique called barbed suture anterior palatoplasty in treating patients with mild to moderate obstructive sleep apnea syndrome (OSAS). A total of 20 patients will undergo this procedure, which involves general anesthesia and bilateral tonsillectomy, followed by specific surgical steps to modify the soft palate. The aim is to assess improvements in sleep apnea symptoms and overall patient outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with mild to moderate obstructive sleep apnea syndrome who have retropalatal collapses and are noncompliant with CPAP.
Not a fit: Patients with severe obstructive sleep apnea, significant craniofacial anomalies, or those unfit for general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new surgical option for patients with mild to moderate obstructive sleep apnea who are noncompliant with CPAP therapy.
How similar studies have performed: While this specific modification may be novel, similar surgical approaches have shown promise in treating obstructive sleep apnea.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mild to moderate obstructive sleep apnea syndrome. * Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses * Patients who are noncompliant with Continuous positive airway pressure (CPAP). Exclusion Criteria: * Patients diagnosed with sever OSAS (AHI more than 30) * The main site of obstruction at retrolingual level or multilevel obstruction. * Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency). * Patients with significant craniofacial anomalies affecting airway. * Patients with BMI\>40 kg/m2. * Patients unfit for general anesthesia. * History of previous velopharyngeal or lingual surgeries.
Where this trial is running
Banhā, Qalyubia Governorate
- Benha University Hospital, Faculty of Medicine — Banhā, Qalyubia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Abdelrahman A Abdelalim, MD — Benha University
- Study coordinator: Abdelrahman A Abdelalim, MD
- Email: aborazan2009@gmail.com
- Phone: 0201069372609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.