Status:
NOT_YET_RECRUITING
Effect of ALA on Retrolingual Collapse in Patients With Multilevel Obstructive OSA
Lead Sponsor:
Assiut University
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
To determine the effect of Anterolateral advancement pharyngoplasty on retrolingual collapse in patients with multilevel OSA, and thus if multistage surgery is required.
Detailed Description
Obstructive sleep apnea (OSA) is a condition characterized by repeated episodes of partial or complete airway obstruction during sleep. It is a common health problem affecting a large proportion of th...
Eligibility Criteria
Inclusion
- Age: ≥ 18 and ≤ 60 years.
- Sex: both genders.
- BMI: less than 32 kg/m2
- Patients with moderate (AHI = 15-30) and severe OSA (AHI \> 30) according to the clinical guidelines given by the American Academy of Sleep Medicine
- Friedman tongue position III or IV.
- Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
- The presence of type II obstruction (oropharynx and hypopharynx).
- Class I occlusion.
Exclusion
- Age: \< 18 or \> 60 years old.
- BMI: \>32 kg/m2
- Failure to attend postoperative follow-up polysomnography within 12 months of surgery.
- Previous surgery to the base of the tongue or other surgical treatment of OSA.
- Chronic pulmonary disease, or other previous oropharyngeal/laryngeal surgery.
- Class II occlusion with receding mandible.
- Huge lymphoid tissue of the tongue and/or lingual tonsil.
- Symptom not suggestive of OSA and presence of central sleep apnea.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06538701
Start Date
October 1 2024
End Date
October 1 2026
Last Update
August 6 2024
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