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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05643352
Other study ID # 18059
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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