Effect of ALA on Retrolingual Collapse in Patients With Multilevel Obstructive OSA
Effect of Anterolateral Advancement Pharyngoplasty on Retrolingual Collapse in Patients With Multilevel Obstructive Sleep Apnea
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ahmed AA Mostafa, Ass lecturer
- Phone Number: +2 01060451679
- Email: dr.ahmed.ayman94@aun.edu.eg
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Anterolateral advancement pharyngoplasty
Starting with bilateral tonsillectomy, The palatopharyngeal muscle (PPM) raised and advanced to be fixed to the pterygomandibular raphe, The posterior part of the PPM, together with its attached mucosa, was then advanced superolaterally behind the palatoglossus muscle to be hooked up to the levator veli palatini muscle
|
Starting with bilateral tonsillectomy, The palatopharyngeal muscle (PPM) raised and advanced to be fixed to the pterygomandibular raphe, The posterior part of the PPM, together with its attached mucosa, was then advanced superolaterally behind the palatoglossus muscle to be hooked up to the levator veli palatini muscle
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determine the changes in apnea-hypopnea index (AHI) in multilevel OSA patients with Anterolateral advancement pharyngoplasty
Time Frame: Baseline
|
we assess pre- and post-operative polysomnogram to detect if there is changes in AHI (per hour of sleep)
|
Baseline
|
|
determine the changes in diameter of retrolingual airway in multilevel OSA patients with Anterolateral advancement pharyngoplasty .
Time Frame: Baseline
|
we assess pre- and post-operative cephalometry to detect if there is changes in diameter of retrolingual airway (in mm).
|
Baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Mohammed AD Mohammed, proffessor, Assiut University
Publications and helpful links
General Publications
- Cahali MB. Lateral pharyngoplasty: a new treatment for obstructive sleep apnea hypopnea syndrome. Laryngoscope. 2003 Nov;113(11):1961-8. doi: 10.1097/00005537-200311000-00020.
- DeRowe A, Gunther E, Fibbi A, Lehtimaki K, Vahatalo K, Maurer J, Ophir D. Tongue-base suspension with a soft tissue-to-bone anchor for obstructive sleep apnea: preliminary clinical results of a new minimally invasive technique. Otolaryngol Head Neck Surg. 2000 Jan;122(1):100-3. doi: 10.1016/S0194-5998(00)70152-5.
- Dicus Brookes CC, Boyd SB. Controversies in Obstructive Sleep Apnea Surgery. Sleep Med Clin. 2018 Dec;13(4):559-569. doi: 10.1016/j.jsmc.2018.07.005.
- Li HY, Lee LA. Relocation pharyngoplasty for obstructive sleep apnea. Laryngoscope. 2009 Dec;119(12):2472-7. doi: 10.1002/lary.20634.
- Powell NB, Riley RW, Guilleminault C. Radiofrequency tongue base reduction in sleep-disordered breathing: A pilot study. Otolaryngol Head Neck Surg. 1999 May;120(5):656-64. doi: 10.1053/hn.1999.v120.a96956.
- Riley R, Guilleminault C, Powell N, Derman S. Mandibular osteotomy and hyoid bone advancement for obstructive sleep apnea: a case report. Sleep. 1984;7(1):79-82. doi: 10.1093/sleep/7.1.79.
- Vicini C, De Vito A, Benazzo M, Frassineti S, Campanini A, Frasconi P, Mira E. The nose oropharynx hypopharynx and larynx (NOHL) classification: a new system of diagnostic standardized examination for OSAHS patients. Eur Arch Otorhinolaryngol. 2012 Apr;269(4):1297-300. doi: 10.1007/s00405-012-1965-z. Epub 2012 Feb 19.
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ALA in OSA patients
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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