search
Back to results

Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

Primary Purpose

Snoring, Sleep-Disordered Breathing

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Barbed reposition pharyngoplasty
Sponsored by
AZ Delta
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2022
Last Updated
December 7, 2022
Sponsor
AZ Delta
search

1. Study Identification

Unique Protocol Identification Number
NCT05643352
Brief Title
Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring
Official Title
Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AZ Delta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Sleep-Disordered Breathing
Keywords
Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Barbed reposition pharyngoplasty
Intervention Description
Barbed reposition pharyngoplasty was performed in all patients
Primary Outcome Measure Information:
Title
Change in Snoring intensity
Description
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
Time Frame
At 2 weeks, at 6 weeks and at 6 months
Title
Change in Snoring severity
Description
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
Time Frame
At 2 weeks, at 6 weeks and at 6 months
Title
Change in Snoring score
Description
Seld-reported subjective score that describes the overall loudness of snoring with score of 0 meaning no snoring and 10 meaning extreme snoring
Time Frame
At 2 weeks, at 6 weeks and at 6 months
Secondary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale
Description
Seld-reported subjective score that evaluates the presence of hypersomnolence. Score out of 24 with 0 meaning no hypersomnolence and 24 extreme hypersomnolence
Time Frame
At 2 weeks, at 6 weeks and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring

We'll reach out to this number within 24 hrs