Effect of ALA on Retrolingual Collapse in Patients With Multilevel Obstructive OSA

NCT06538701 | Not Yet Recruiting

• 1 other identifier: ALA in OSA patients
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• determine the changes in apnea-hypopnea index (AHI) in multilevel OSA patients with Anterolateral advancement pharyngoplasty

  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 .

  we assess pre- and post-operative cephalometry to detect if there is changes in diameter of retrolingual airway (in mm).

  Baseline

Study Arms (1)

Anterolateral advancement pharyngoplasty

EXPERIMENTAL

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

Procedure: Anterolateral advancement pharyngoplasty

Interventions

Anterolateral advancement pharyngoplasty PROCEDURE

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

Anterolateral advancement pharyngoplasty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 14603056 BACKGROUND

• 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.

  PMID: 10629491 BACKGROUND

• 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.

  PMID: 30396449 BACKGROUND

• Li HY, Lee LA. Relocation pharyngoplasty for obstructive sleep apnea. Laryngoscope. 2009 Dec;119(12):2472-7. doi: 10.1002/lary.20634.

  PMID: 19688851 BACKGROUND

• 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.

  PMID: 10229589 BACKGROUND

• 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.

  PMID: 6718928 BACKGROUND

• 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.

  PMID: 22350494 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohammed AD Mohammed, proffessor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed AA Mostafa, Ass lecturer

CONTACT

01060451679; dr.ahmed.ayman94@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 6, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-07