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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04928404

Enrollment

Registered

2021-06-16

Start date

2021-06-12

Completion date

2022-12-30

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

tongue base, tongue base suspension, barbed suture

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.

Interventions

PROCEDUREtongue 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
changes in obstructive sleep apnea	3 months after intervention	using polysomnography

Countries

Egypt

Contacts

Primary ContactMohameed Moussa, specialist

mabdelmatien_post@med.sohag.edu.eg01011178222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026