Sleep-Disordered Breathing, Snoring
Conditions
Keywords
Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery
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.
Interventions
PROCEDUREBarbed reposition pharyngoplasty
Barbed reposition pharyngoplasty was performed in all patients
Sponsors
AZ Delta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed