Clinical trial NCT01955083: Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
Official title: Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Snoring
Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
snoring
radiofrequency
pillar implant
snore sound analysis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2013-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. simple snoring or mild obstructive sleep apnea
2. major complaint of snoring
3. favorable anatomic structure for minimal invasive surgery.

Exclusion Criteria:

1. moderate or severe obstructive sleep apnea
2. pathological obesity
3. significant craniofacial anomaly
4. elderly
5. unfavorable anatomic structure for minimal invasive surgery.

Primary outcomes:
measure: Change in VAS Score After MIS
timeFrame: baseline and 3 months following surgery
Secondary outcomes:
measure: Change in SOS Score After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in Total-SI After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in Total-Imax After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in Total-Imean After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in Total-Fpeak After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in Total-Fmean After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in B1-SI After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in B1-Imax After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in B1-Imean After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in B1-Fpeak After MIS
timeFrame: baseline and 3 months following surgery
measure: Percent Change in B1-Fmean After MIS
timeFrame: baseline and 3 months following surgery
Other outcomes:
Locations:
city: Kweishan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Hsueh Yu Li, professor
role: STUDY_CHAIR
References:
citation: 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.