At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
In Brief
A clinical study evaluating Pillar implant and Radiofrequency for Primary Snoring and Obstructive Sleep Apnea. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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).