Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT03788668
Eligibility Criteria:
Inclusion Criteria:
1. Adult patients of both sexes between 18-60 years old.
2. Moderate to severe obstructive sleep apnea diagnosed by sleep study with apnea hypopnea index (AHI) \> 15/h.
3. Body mass index (BMI) \<35.
4. Refusing or intolerable to use continuous positive airway pressure.
5. Lateral pharyngeal wall collapse diagnosed by drug induced sleep endoscopy.
6. Patients who underwent previous tonsillectomy, adenoidectomy or previous nasal surgeries can be included.
Exclusion Criteria:
1. Patients who are unfit for surgeries.
2. Patients who are tolerable to continuous positive airway pressure.
3. Patients who underwent any palatal, pharyngeal, oral, mandibular, maxillofacial surgeries.
4. Patients with central sleep apnea and neurological syndromes.
5. Patients with neck, cervical vertebral pathologies and hypothyroidism.
6. Patients who had facial skeletal abnormalities.
7. Patients who had kissing tonsils or adenoids or huge tongue base.
8. Patients who have other level of obstruction (beside oropharyngeal lateral wall collapse and hypopharyngeal retro lingual obstruction) will be excluded or have this level of obstruction completely managed before recruitment in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03788668
Study Brief:
Protocol Section:
NCT03788668