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Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

A

AZ Delta

Status

Active, not recruiting

Conditions

Snoring
Sleep-Disordered Breathing

Treatments

Procedure: Barbed reposition pharyngoplasty

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The aim of the study is to determine whether there is a statistically significant difference in snoring intensity before and after performing a Barbed Reposition Pharyngoplasty as a single-level snoring procedure. The investigators aim to determine whether this is a valid alternative to the more classical techniques of pharyngoplasty. Furthermore, the investigators also wish to map the various postoperative complications and compare them with those of the more conventional techniques. The investigators compare the snoring intensity before surgery with the snoring intensity at 2 weeks (first postoperative control), at 6 weeks (second postoperative control) and at 6 months (Third postoperative control).

For the evaluation of snoring, the investigators use 4 scales/questionnaires. These questionnaires are currently also used as standard at the outpatient clinic for snoring problems. These 4 scales/questionnaires are completed at every check-up.

During the first postoperative check-up, the postoperative side effects are checked (bleeding, infection, readmission, needed consultation with another doctor, date of resumption of work). The investigators also map the pain with a visual analog scale and measure this the day after the operation and let the patient fill it in 3 days, 1 week and 2 weeks after the operation.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • single-level retro-palatal collapse observed during drug-induced sleep endoscopy (DISE)

Exclusion criteria

  • OSAS defined as having an obstructive AHI (OAHI) ≥ 30
  • Obese patients with a body mass index (BMI) ≥ 30 kg/m².
  • Patients with multilevel airway collapse observed during DISE
  • Patients younger than 18 years old.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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