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

NCT04928404 | Unknown

• 1 other identifier: Soh-med-21-06-12
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

tongue base; tongue base suspension; barbed suture

Outcome Measures

Primary Outcomes (1)

• changes in obstructive sleep apnea

  using polysomnography

  3 months after intervention

Study Arms (1)

obstructive sleep apnea patients

OTHER

Procedure: tongue base suspension using barbed suture

Interventions

tongue base suspension using barbed suture PROCEDURE

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.

obstructive sleep apnea patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Mohameed Moussa, specialist

CONTACT

01011178222; mabdelmatien_post@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otorhinolaryngology specialist

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 16, 2021
• Study Start: June 12, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)