Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Snoring; Sleep-Disordered Breathing
• Intervention / Treatment: Procedure: Barbed reposition pharyngoplasty

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Roeselare, Belgium, 8800
    • Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Snoring intensity	Seld-reported subjective score from 0 to 10 that describes the impact of snoring with 0 meaning no snoring and 10 meaning sleeping separately from partner	At 2 weeks, at 6 weeks and at 6 months
Change in Snoring severity	Seld-reported subjective score that describes the severity of snoring (frequency, duration,...). Score from 0 to 9 with 0 meaning never snoring and 9 meaning snoring every night during the entire night with sounds audible from another floor	At 2 weeks, at 6 weeks and at 6 months
Change in Snoring score	Seld-reported subjective score that describes the overall loudness of snoring with score of 0 meaning no snoring and 10 meaning extreme snoring	At 2 weeks, at 6 weeks and at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Epworth Sleepiness Scale	Seld-reported subjective score that evaluates the presence of hypersomnolence. Score out of 24 with 0 meaning no hypersomnolence and 24 extreme hypersomnolence	At 2 weeks, at 6 weeks and at 6 months

Collaborators and Investigators

• Sponsor: AZ Delta

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Surgery; Snoring; Pharyngoplasty; Barbed reposition pharyngoplasty
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Snoring
• Other Study ID Numbers: 18059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No