Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients

Overview

Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events. One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea. DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2022

Interventions

  • Procedure: tongue base suspension using barbed suture
    • all patients will undergo multi-level surgeries .Therefor, Anterolateral advancement pharyngeoplasty (ALA) or Barbed Reposition Pharyngoplasty (BRP) will be applied to improve retro-palatal obstruction and tongue base suspension using barbed suture for retro-lingual obstruction.

Arms, Groups and Cohorts

  • Other: obstructive sleep apnea patients

Clinical Trial Outcome Measures

Primary Measures

  • changes in obstructive sleep apnea
    • Time Frame: 3 months after intervention
    • using polysomnography

Participating in This Clinical Trial

Inclusion Criteria

  • BMI of patients less than 35 kg/m2. – Patients who have symptoms and signs of OSA. – Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15). – 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 retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver. – Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm. Exclusion Criteria:

  • Failure to attend postoperative follow-up polysomnography within 6 months of surgery. – Previous surgery to the base of the tongue or other surgical treatment of OSAHS. – A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery. – Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º. – Huge lymphoid tissue of the tongue and/or lingual tonsil.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sohag University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammed Abd Elmateen Moussa, Otorhinolaryngology specialist – Sohag University
  • Overall Contact(s)
    • Mohameed Moussa, specialist, 01011178222, mabdelmatien_post@med.sohag.edu.eg

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