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

NCT ID: NCT04928404

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-12
• Study Completion Date: 2022-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

obstructive sleep apnea patients

Group Type: OTHER

tongue base suspension using barbed suture

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abd Elmateen Moussa

Otorhinolaryngology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohameed Moussa, specialist

Role: CONTACT

mabdelmatien_post@med.sohag.edu.eg

01011178222

Facility Contacts

hassan noamen, professor

Role: primary

portal@med.sohag.edu.eg

Other Identifiers

Soh-med-21-06-12

Identifier Type: -

Identifier Source: org_study_id