Treatment of obstructive sleep apnea with expansion palatoplasty
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
This study tests if a surgery called expansion palatoplasty can help adults with mild to moderate obstructive sleep apnea breathe better during sleep.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06283095 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of expansion palatoplasty as a treatment for adults suffering from obstructive sleep apnea syndrome (OSAS). The procedure aims to address the anatomical issues contributing to airway obstruction during sleep. Participants will undergo the surgery, and the outcomes will be assessed to determine the procedure's success in managing OSAS symptoms. The study focuses on patients with mild to moderate OSAS and specific anatomical characteristics as confirmed by drug-induced sleep endoscopy.
Who should consider this trial
Good fit: Ideal candidates are adults with a body mass index under 30 kg/m2 and mild to moderate obstructive sleep apnea.
Not a fit: Patients with severe obstructive sleep apnea or those with contraindications to anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and overall health for patients with obstructive sleep apnea.
How similar studies have performed: While there may be existing studies on surgical interventions for sleep apnea, the specific approach of expansion palatoplasty is less commonly evaluated, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Asyut
- Assuit — Asyut, Egypt (Recruiting)
Study contacts
- Principal investigator: Enas T Zarief — Assuit U
- Study coordinator: Enas T Zarief
- Email: enas.tharwat23@gmail.com
- Phone: 01226270800
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.