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

Primary Purpose

Obstructive Sleep Apnea

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

tongue base suspension using barbed suture

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring tongue base, tongue base suspension, barbed suture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sohag universityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

obstructive sleep apnea patients

Arm Description

Outcomes

Primary Outcome Measures

changes in obstructive sleep apnea

using polysomnography

Secondary Outcome Measures

Full Information

NCT ID

NCT04928404

First Posted

June 15, 2021

Last Updated

June 16, 2021

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04928404

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 12, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

tongue base, tongue base suspension, barbed suture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

obstructive sleep apnea patients

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

tongue base suspension using barbed suture

Intervention Description

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.

Primary Outcome Measure Information:

Title

changes in obstructive sleep apnea

Description

using polysomnography

Time Frame

3 months after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohameed Moussa, specialist

Phone

01011178222

mabdelmatien_post@med.sohag.edu.eg

Facility Information:

Facility Name

Sohag university

City

Sohag

ZIP/Postal Code

82524

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hassan noamen, professor

portal@med.sohag.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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