N/A
N=30
Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
Primary Snoring · Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01955083 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in VAS Score After MIS — -1.4; -3.3 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pillar implant (Device); Radiofrequency (Device)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in VAS Score After MIS |
-1.4; -3.3 | <0.05 sig |
| SECONDARY Change in SOS Score After MIS |
13.0; 22.8 | <0.05 sig |
| SECONDARY Percent Change in Total-SI After MIS |
-48.9; -5.9 | <0.05 sig |
| SECONDARY Percent Change in Total-Imax After MIS |
11.3; -6.8 | <0.05 sig |
| SECONDARY Percent Change in Total-Imean After MIS |
18.2; -0.4 | <0.05 sig |
| SECONDARY Percent Change in Total-Fpeak After MIS |
-12.1; -6 | <0.05 sig |
| SECONDARY Percent Change in Total-Fmean After MIS |
-10.9; -0.9 | <0.05 sig |
| SECONDARY Percent Change in B1-SI After MIS |
-51.8; -1.7 | <0.05 sig |
| SECONDARY Percent Change in B1-Imax After MIS |
5.6; -9.4 | <0.05 sig |
| SECONDARY Percent Change in B1-Imean After MIS |
14.7; -4.6 | <0.05 sig |
| SECONDARY Percent Change in B1-Fpeak After MIS |
-33.5; -10.9 | <0.05 sig |
| SECONDARY Percent Change in B1-Fmean After MIS |
-24.8; -1.6 | <0.05 sig |
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. 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.
2. Purposes:
1. Development of snore sound spectrum.
2. Exploration of the correlation between subjective perception and objective assessment of snoring.
3. 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.
3. 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.
4. Outcomes
1. Development of snore sound spectrum in sleep-disorder breathing patients.
2. Correlation of parameters between snore sound recording (loudness, frequency, count, regularity, etc ) and clinical parameters.
3. Correlation between objective (snore sound analysis) and subjective (SOS,VAS) assessment of snoring.
4. Comparison of changes in snoring (particular in objective assessment) after radiofrequency or pillar implant.
5. Comparison of changes in snoring between radiofrequency and pillar implant.
Eligibility Criteria
Inclusion Criteria
- simple snoring or mild obstructive sleep apnea
- major complaint of snoring
- favorable anatomic structure for minimal invasive surgery.
Exclusion Criteria
- moderate or severe obstructive sleep apnea
- pathological obesity
- significant craniofacial anomaly
- elderly
- unfavorable anatomic structure for minimal invasive surgery.
Data sourced from ClinicalTrials.gov (NCT01955083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.