Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

Not Applicable

Active, not recruiting

• Conditions: Snoring; Sleep-Disordered Breathing

• Registration Number: NCT05643352
• Lead Sponsor: AZ Delta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Snoring score	At 2 weeks, at 6 weeks and at 6 months	Seld-reported subjective score that describes the overall loudness of snoring with score of 0 meaning no snoring and 10 meaning extreme snoring
Change in Snoring intensity	At 2 weeks, at 6 weeks and at 6 months	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
Change in Snoring severity	At 2 weeks, at 6 weeks and at 6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta; 🇧🇪 Roeselare, Belgium