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

Last updated: June 16, 2021
Sponsor: Sohag University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT04928404
Soh-med-21-06-12
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 limitedto continuous positive airway pressure).
  • The presence of retrolingual collapse confirmed preoperatively with flexiblefiberoptic endoscope during Muller maneuver.
  • Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.

Exclusion

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, orother previous oropharyngeal/laryngeal surgery.
  • Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
  • Huge lymphoid tissue of the tongue and/or lingual tonsil.

Study Design

Total Participants: 13
Study Start date:
June 12, 2021
Estimated Completion Date:
December 30, 2022

Connect with a study center

  • Sohag university

    Sohag, 82524
    Egypt

    Active - Recruiting

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