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

Sohag University

Status

Unknown

Conditions

Obstructive Sleep Apnea

Treatments

Procedure: tongue base suspension using barbed suture

Study type

Interventional

Funder types

Other

Identifiers

NCT04928404

Soh-med-21-06-12

Details and patient eligibility

About

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.

Enrollment

13 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.