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

Not Applicable

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04928404
• Lead Sponsor: Sohag University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-12
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
changes in obstructive sleep apnea	3 months after intervention	using polysomnography

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt