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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928404
• Other study ID #: Soh-med-21-06-12
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: June 2021
• Source: Sohag University
• Contact: Mohameed Moussa, specialist
• Phone: 01011178222
• Email: mabdelmatien_post[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in obstructive sleep apnea	using polysomnography	3 months after intervention