SnoringNCT05643352
Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring
A study testing Barbed reposition pharyngoplasty in people with Snoring and Sleep-Disordered Breathing, run by AZ Delta at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Sleep-Disordered Breathing
- What is being tested?
- Barbed reposition pharyngoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single-level retro-palatal collapse observed during drug-induced sleep endoscopy (DISE)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta
Roeselare, 8800
About this study
Official title: Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study
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.
- Conditions
- Snoring, Sleep-Disordered Breathing
- Being tested
- Barbed reposition pharyngoplasty
- Keywords
- Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery
- Medical subject headings
- Snoring, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed reposition pharyngoplastyProcedure or surgery
Barbed reposition pharyngoplasty was performed in all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 2 weeks, at 6 weeks and at 6 months
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
Measured: At 2 weeks, at 6 weeks and at 6 months
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
Measured: At 2 weeks, at 6 weeks and at 6 months
Secondary outcomes (1)
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
Measured: At 2 weeks, at 6 weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Oct 2022
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Delta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643352
- Sponsor's protocol ID
- 18059
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study
- ClinicalTrials.gov ID
- NCT05643352
- Acronym / sponsor ID
- 18059
- Conditions
- Snoring, Sleep-Disordered Breathing
- Keywords
- Pharyngoplasty, Barbed reposition pharyngoplasty, Snoring, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AZ DeltaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single-level retro-palatal collapse observed during drug-induced sleep endoscopy (DISE)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed reposition pharyngoplastyBarbed reposition pharyngoplasty was performed in all patients | Procedure or surgery | – |
Primary outcome
Change in Snoring intensity
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Change in Epworth Sleepiness Scale
Time frame: At 2 weeks, at 6 weeks and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed reposition pharyngoplasty in people with Snoring and Sleep-Disordered Breathing, run by AZ Delta at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Snoring intensity (time frame: At 2 weeks, at 6 weeks and at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.