Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

NCT05643352 | Unknown

• 1 other identifier: 18059
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Pharyngoplasty; Barbed reposition pharyngoplasty; Snoring; Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Epworth Sleepiness Scale

  At 2 weeks, at 6 weeks and at 6 months

Interventions

Barbed reposition pharyngoplasty PROCEDURE

Barbed reposition pharyngoplasty was performed in all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AZ Delta: lead

Study Sites (1)

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

Roeselare, 8800, Belgium

Location

MeSH Terms

Conditions

Snoring; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 8, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)