Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

NCT ID: NCT05643352

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-02-28

Brief Summary

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.

Conditions

Snoring; Sleep-Disordered Breathing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Barbed reposition pharyngoplasty

Barbed reposition pharyngoplasty was performed in all patients

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Delta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta

Roeselare, , Belgium

Countries

Belgium

Other Identifiers

18059

Identifier Type: -

Identifier Source: org_study_id