Obstructive Sleep Apnea Clinical Trial
Official title:
Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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