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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: tongue base suspension using barbed suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: obstructive sleep apnea patients<br> | Procedure: tongue base suspension using barbed suture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in obstructive sleep apnea | using polysomnography | 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tongue base, tongue base suspension, barbed suture