Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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：
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pillar implant | Experimental | Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. |
|
| Radiofrequency | Active Comparator | Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pillar implant | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS Score After MIS | The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement. | baseline and 3 months following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SOS Score After MIS | Change in SOS score at 3 months after radiofrequency or pillar implant were calculated. | baseline and 3 months following surgery |
| Percent Change in Total-SI After MIS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hsueh Yu Li, professor | Chang Gung Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kweishan | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24816691 | Background | 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. |
| Label | URL |
|---|---|
| Chang Gung Memorial Hospital at Linkou is a tertiary medical center in Taiwan (R.O.C.). | View source |
Not provided
The additional inclusion criteria were: a) length of the soft palate ≥ 2.5 cm and b) the width of the base of the uvular ≥ 1.0 cm. The exclusion criteria were: a) tonsillar hypertrophy; b) high tongue position; c) retrognathia; d) craniofacial abnormalities, e) trismus, f) allergy to anesthetic, and g) poorly controlled medical disorders.
This study was a prospective, randomized, parallel-controlled trial in a tertiary medical center (Department of Otorhinolaryngology, Head and Neck Surgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan). Subjects were recruitment from October 1, 2010 to March 31, 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency | Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. 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). |
| FG001 | Pillar Implant | Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency | Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. |
| BG001 | Pillar Implant | Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in VAS Score After MIS | The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement. | Twenty-eight patients completed the protocol; two study cases were not available for follow-up. Fourteen patients underwent radiofrequency surgery and 14 patients received pillar implant surgery. Accordingly, we analyzed the participants who completed the study protocol. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 3 months following surgery |
|
Adverse event data was collected in 3 months.
No known serious adverse event had been reported to our literature review. Other adverse events of radiofrequency surgery were mucosal ulcers and breakdown. Known other adverse event of pillar implant was protrusion of implant.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency | Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. |
Not provided
Not provided
The major limitations to this study were unbalanced randomization in Total-Imax despite insignificant differences in other baseline parameters between the two groups and the small sample size of the study limited the subgroup analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsueh-Yu Li | Chang Gung Memorial Hospital | 886-3-3281200 | 3967 | hyli38@adm.cgmh.org.tw |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Radiofrequency | Device | 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). |
|
|
Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline and 3 months following surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| VAS | The participants, based on descriptions from their spouse or bed partner, were asked to estimate the severity of their snoring using a 10 cm visual analogue scale (VAS) from 0 (no snoring) to 10 (very severe snoring, bed partner leaves the room). | Mean | Standard Deviation | units on a scale |
|
| SOS | The Mandarin Chinese version of the Snore Outcomes Survey (SOS) questionnaire has been validated and repeatedly used as an outcome measure in obstructive sleep apnea patients. It was comprised of eight Likert-type items to comprehensively evaluate the duration, loudness, and frequency of snoring. The scale of the SOS was normalized from 0 (worst) to 100 (best). | Mean | Standard Deviation | units on a scale |
|
| Total-SI | We calculated the snoring index (SI) of the total frequency domain (40 Hz-2,000 Hz) as 'Total-SI'. | Mean | Standard Deviation | event/hour |
|
| Total-Imax | We calculated the maximal sound intensity (Imax) of the total frequency domain (40 Hz-2,000 Hz) as 'Total-Imax'. | Mean | Standard Deviation | dB |
|
| Total-Imean | We calculated the mean sound intensity (Imean) of the total frequency domain (40 Hz-2,000 Hz) as 'Total-Imean'. | Mean | Standard Deviation | dB |
|
| Total-Fpeak | We calculated the peak sound frequency (Fpeak) of the total frequency domain (40 Hz-2,000 Hz) as 'Total-Fpeak'. | Mean | Standard Deviation | Hz |
|
| Total-Fmean | We calculated the mean sound frequency (Fmean) of the total frequency domain (40 Hz-2,000 Hz) as 'Total-Fmean'. | Mean | Standard Deviation | Hz |
|
| B1-SI | We calculated the snoring index (SI) of the low frequency domain (40 Hz-300 Hz) as 'B1-SI'. | Mean | Standard Deviation | event/hour |
|
| B1-Imax | We calculated the maximal sound intensity (Imax) of the low frequency domain (40 Hz-300 Hz) as 'B1-Imax'. | Mean | Standard Deviation | dB |
|
| B1-Imean | We calculated the mean sound intensity (Imean) of the low frequency domain (40 Hz-300 Hz) as 'B1-Imean'. | Mean | Standard Deviation | dB |
|
| B1-Fpeak | We calculated the peak sound frequency (Fpeak) of the low frequency domain (40 Hz-300 Hz) as 'B1-Fpeak'. | Mean | Standard Deviation | Hz |
|
| B1-Fmean | We calculated the mean sound frequency (Fmean) of the low frequency domain (40 Hz-300 Hz) as 'B1-Fmean'. | Mean | Standard Deviation | Hz |
|
| OG001 |
| Change in VAS Score at 3 Months After Pillar Implant |
Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated. |
|
|
|
| Secondary | Change in SOS Score After MIS | Change in SOS score at 3 months after radiofrequency or pillar implant were calculated. | Twenty-eight participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Total-SI | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Total-Imax | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Total-Imean | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Total-Fpeak | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Total-Fmean | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of B1-SI | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of B1-Imax | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of B1-Imean | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of B1-Fpeak | baseline and 3 months following surgery |
|
|
|
|
| Secondary | 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. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of B1-Fmean | baseline and 3 months following surgery |
|
|
|
|
| Post-Hoc | Percentage of Good Response After MIS | Postoperative 'VAS <=3' was traditionally defined as 'major response'. For a comprehensive profile of the outcomes, we further created another definition of 'fine response': 'postoperative VAS <=5 plus SOS >=60' post hoc in the present study. Accordingly, patients with a postoperative VAS <=3 or postoperative VAS <=5 plus SOS >=60' group was considered to have a 'good response'. Therefore, we calculated the 'good response' rate in the radiofrequency and pillar implant groups. | A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery. | Posted | Mean | Standard Error | percentage of Good Response | baseline and 3 months following surgery |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Pillar Implant | Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. | 0 | 15 | 0 | 15 |
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |