Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05643352
• Other study ID #: 18059
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: February 2023

Study information

• Verified date: December 2022
• Source: AZ Delta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep-Disordered Breathing
• Snoring

Intervention

Procedure:
• Barbed reposition pharyngoplasty
Barbed reposition pharyngoplasty was performed in all patients

Locations

Country	Name	City	State
Belgium	Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
AZ Delta

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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