Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

Study Overview
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Brief Summary
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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.

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

Conditions
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Snoring, Sleep-Disordered Breathing

Intervention / Treatment
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* Procedure: Barbed reposition pharyngoplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Barbed reposition pharyngoplasty|Barbed reposition pharyngoplasty was performed in all patients|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery