Primary SnoringNCT01955083
Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
A study testing Pillar implant and Radiofrequency in people with Primary Snoring and Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
1. Background：The methods of anti-snore (treatment of snoring ) can be divided into conservative, invasive and minimal invasive treatment. IN brief, minimal invasive surgery involving radiofrequency and pillar implant demonstrates significantly improvement of snoring without major complication. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Primary Snoring, Obstructive Sleep Apnea
- What is being tested?
- Pillar implant and Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- simple snoring or mild obstructive sleep apnea
- major complaint of snoring
- favorable anatomic structure for minimal invasive surgery.
Who cannot join
- moderate or severe obstructive sleep apnea
- pathological obesity
- significant craniofacial anomaly
- elderly
- unfavorable anatomic structure for minimal invasive surgery.
Trial locations and contacts
1 site in 1 country.
About this study
- Background：The methods of anti-snore (treatment of snoring ) can be divided into conservative, invasive and minimal invasive treatment. IN brief, minimal invasive surgery involving radiofrequency and pillar implant demonstrates significantly improvement of snoring without major complication. Previous studies usually evaluated snoring through subjective measures such as visual analog scale visual analog scale. Rare reports analyzed snore sound instrumentally and no report demonstrates the correlation between subjective perception and objective assessment of snoring before and after surgical intervention.
- Purposes：
- Development of snore sound spectrum.
- Exploration of the correlation between subjective perception and objective assessment of snoring.
- Comparison of changes in snoring before and after minimal invasive surgery and between two kinds of MIS to have a understanding of surgical impact in subjective and objective measurement.
- Method：We plan to enroll 30 subjects diagnosed by polysomnography as simple snoring or mild OSA with major complaint of snoring and favorable anatomic structure for minimal invasive surgery. All eligible subjects will be instructed the purpose, process and all related rights of this study and sign inform consent in outpatient clinic. Subjects start to complete Snore Outcome Survey (SOS, a validated questionnaire) and visual analog sure of snoring (VAS). Objective overnight snore sound recoding is arranged in sleep center. Subjects then receive minimal invasive surgery：radiofrequency or pillar implant of the soft palate by randomization. Both radiofrequency and pillar implant are common techniques in treating snoring and performed under local anesthesia as an outpatient procedure on sitting position. All subjects received repeated snore sound recording and completion of SOS and VAS three months after MIS.
- Outcomes
- Development of snore sound spectrum in sleep-disorder breathing patients.
- Correlation of parameters between snore sound recording (loudness, frequency, count, regularity, etc ) and clinical parameters.
- Correlation between objective (snore sound analysis) and subjective (SOS,VAS) assessment of snoring.
- Comparison of changes in snoring (particular in objective assessment) after radiofrequency or pillar implant.
- Comparison of changes in snoring between radiofrequency and pillar implant.
Read the detailed description
Recent publications have demonstrated reductions in snoring with several minimal invasive surgery (MIS) methods of the soft palate including radiofrequency (RF) surgery and pillar implant (PI). Despite modest effects in the treatment of obstructive sleep apnea, patients often wish to receive MIS for habitual snoring. However, the efficacy in reducing snoring has mainly been determined by self-reported questionnaires in the past. Further, the definition of surgical success in snoring treatment has not been universally defined. To date, changes in snoring sound characteristics following MIS have not been demonstrated.
Many cohort studies and a few randomized controlled trials or clinical controlled trials have compared MIS with a placebo, different energy generators, different material rigidity, or different operative techniques. RF of the soft palate produces volumetric tissue reduction and selective scar tissue5 to reduce obstruction and induce stiffness. However, the RF energy delivered to the soft palate can be inadequate and may result in residual or recurrent snoring. PI can decrease palatal flutter by increasing the rigidity of the soft palate through implant identity and tissue fibrosis. In addition, PI can be chronically retained in the muscle layer of the soft palate thereby producing a long-term anti-snoring effect. Nevertheless, whether PI provides a better efficacy in the treatment of snoring than RF surgery is still unknown.
The primary aim of the current study was to compare the anti-snoring effect between PI and RF by subjective assessments in a randomized controlled parallel trial. The secondary aim was to explore and compare the acoustic changes in snoring sounds after PI and RF.
- Conditions
- Primary Snoring, Obstructive Sleep Apnea
- Being tested
- Pillar implant, Radiofrequency
- Keywords
- Obstructive sleep apnea, snoring, radiofrequency, pillar implant, snore sound analysis
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillar implantDevice
Also called Pillar implant (Medtronic Inc., USA)
Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant.
RadiofrequencyDevice
Also called Somnus® Model S2 (Gyrus-ACMI Corporation, USA)
Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance).
| Study group | Role | What they receive |
|---|---|---|
| Pillar implant | Experimental | Arm 1- Pillar implant (Study group):
15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Receives: Device: Pillar implant |
| Radiofrequency | Active comparator | Arm 2- Radiofrequency (control group):
15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS Score After MIS
The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.
Measured: baseline and 3 months following surgery
Secondary outcomes (11)
Change in SOS Score After MIS
Change in SOS score at 3 months after radiofrequency or pillar implant were calculated.
Measured: baseline and 3 months following surgery
Percent Change in Total-SI After MIS
Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in Total-Imax After MIS
Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in Total-Imean After MIS
Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in Total-Fpeak After MIS
Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in Total-Fmean After MIS
Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in B1-SI After MIS
Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in B1-Imax After MIS
Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in B1-Imean After MIS
Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in B1-Fpeak After MIS
Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Percent Change in B1-Fmean After MIS
Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated.
Measured: baseline and 3 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startAug 2010
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary SnoringStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hsueh Yu Li, professor, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955083
- Sponsor's protocol ID
- hyli38
- Status last verified
- Oct 2013
- First submitted
- 29 Jul 2010
- Last updated
- 18 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee LA, Yu JF, Lo YL, Chen NH, Fang TJ, Huang CG, Cheng WN, Li HY. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial. PLoS One. 2014 May 9;9(5):e97186. doi: 10.1371/journal.pone.0097186. eCollection 2014.
PubMed 24816691
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
- ClinicalTrials.gov ID
- NCT01955083
- Acronym / sponsor ID
- hyli38
- Conditions
- Primary Snoring, Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, snoring, radiofrequency, pillar implant, snore sound analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Posted 18 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Background：The methods of anti-snore (treatment of snoring ) can be divided into conservative, invasive and minimal invasive treatment. IN brief, minimal invasive surgery involving radiofrequency and pillar implant demonstrates significantly improvement of snoring without major complication. Previous studies usually evaluated snoring through subjective measures such as visual analog scale visual analog scale. Rare reports analyzed snore sound instrumentally and no report demonstrates the correlation between subjective perception and objective assessment of snoring before and after surgical intervention.
- Purposes：
- Development of snore sound spectrum.
- Exploration of the correlation between subjective perception and objective assessment of snoring.
- Comparison of changes in snoring before and after minimal invasive surgery and between two kinds of MIS to have a understanding of surgical impact in subjective and objective measurement.
- Method：We plan to enroll 30 subjects diagnosed by polysomnography as simple snoring or mild OSA with major complaint of snoring and favorable anatomic structure for minimal invasive surgery. All eligible subjects will be instructed the purpose, process and all related rights of this study and sign inform consent in outpatient clinic. Subjects start to complete Snore Outcome Survey (SOS, a validated questionnaire) and visual analog sure of snoring (VAS). Objective overnight snore sound recoding is arranged in sleep center. Subjects then receive minimal invasive surgery：radiofrequency or pillar implant of the soft palate by randomization. Both radiofrequency and pillar implant are common techniques in treating snoring and performed under local anesthesia as an outpatient procedure on sitting position. All subjects received repeated snore sound recording and completion of SOS and VAS three months after MIS.
- Outcomes
- Development of snore sound spectrum in sleep-disorder breathing patients.
- Correlation of parameters between snore sound recording (loudness, frequency, count, regularity, etc ) and clinical parameters.
- Correlation between objective (snore sound analysis) and subjective (SOS,VAS) assessment of snoring.
- Comparison of changes in snoring (particular in objective assessment) after radiofrequency or pillar implant.
- Comparison of changes in snoring between radiofrequency and pillar implant.
Detailed description
Recent publications have demonstrated reductions in snoring with several minimal invasive surgery (MIS) methods of the soft palate including radiofrequency (RF) surgery and pillar implant (PI). Despite modest effects in the treatment of obstructive sleep apnea, patients often wish to receive MIS for habitual snoring. However, the efficacy in reducing snoring has mainly been determined by self-reported questionnaires in the past. Further, the definition of surgical success in snoring treatment has not been universally defined. To date, changes in snoring sound characteristics following MIS have not been demonstrated.
Many cohort studies and a few randomized controlled trials or clinical controlled trials have compared MIS with a placebo, different energy generators, different material rigidity, or different operative techniques. RF of the soft palate produces volumetric tissue reduction and selective scar tissue5 to reduce obstruction and induce stiffness. However, the RF energy delivered to the soft palate can be inadequate and may result in residual or recurrent snoring. PI can decrease palatal flutter by increasing the rigidity of the soft palate through implant identity and tissue fibrosis. In addition, PI can be chronically retained in the muscle layer of the soft palate thereby producing a long-term anti-snoring effect. Nevertheless, whether PI provides a better efficacy in the treatment of snoring than RF surgery is still unknown.
The primary aim of the current study was to compare the anti-snoring effect between PI and RF by subjective assessments in a randomized controlled parallel trial. The secondary aim was to explore and compare the acoustic changes in snoring sounds after PI and RF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pillar implant | Experimental | Device: Pillar implantArm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. |
| Radiofrequency | Active comparator | Device: RadiofrequencyArm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- simple snoring or mild obstructive sleep apnea
- major complaint of snoring
- favorable anatomic structure for minimal invasive surgery.
Key exclusion criteria (5 listed)
- moderate or severe obstructive sleep apnea
- pathological obesity
- significant craniofacial anomaly
- elderly
- unfavorable anatomic structure for minimal invasive surgery.
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 |
|---|---|---|
| Pillar implantAlso: Pillar implant (Medtronic Inc., USA)Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant. | Device | Pillar implant |
| RadiofrequencyAlso: Somnus® Model S2 (Gyrus-ACMI Corporation, USA)Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance). | Device | Radiofrequency |
Primary outcome
Change in VAS Score After MIS
Time frame: baseline and 3 months following surgery
The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.
11 secondary outcomes
Change in SOS Score After MIS
Time frame: baseline and 3 months following surgery
Percent Change in Total-SI After MIS
Time frame: baseline and 3 months following surgery
Percent Change in Total-Imax After MIS
Time frame: baseline and 3 months following surgery
Percent Change in Total-Imean After MIS
Time frame: baseline and 3 months following surgery
Percent Change in Total-Fpeak After MIS
Time frame: baseline and 3 months following surgery
Percent Change in Total-Fmean After MIS
Time frame: baseline and 3 months following surgery
Percent Change in B1-SI After MIS
Time frame: baseline and 3 months following surgery
Percent Change in B1-Imax After MIS
Time frame: baseline and 3 months following surgery
Percent Change in B1-Imean After MIS
Time frame: baseline and 3 months following surgery
Percent Change in B1-Fpeak After MIS
Time frame: baseline and 3 months following surgery
Percent Change in B1-Fmean After MIS
Time frame: baseline and 3 months following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24816691Lee LA, Yu JF, Lo YL, Chen NH, Fang TJ, Huang CG, Cheng WN, Li HY. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial. PLoS One. 2014 May 9;9(5):e97186. doi: 10.1371/journal.pone.0097186. eCollection 2014.
- Chang Gung Memorial Hospital at Linkou is a tertiary medical center in Taiwan (R.O.C.).Link provided by the sponsor.
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.
Hsueh Yu Li, professor study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillar implant and Radiofrequency in people with Primary Snoring and Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Aug 2014. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 VAS Score After MIS (time frame: baseline and 3 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955083, which also lists 1 linked publication.
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 18 Aug 2014.