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: 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
- 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
- changes in obstructive sleep apnea
- Time Frame: 3 months after intervention
- using polysomnography
Participating in This Clinical Trial
- 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
- 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, email@example.com
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