Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients

NCT01955083 | Completed Results DMC

• 1 other identifier: hyli38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Purposes：
3. 3.Development of snore sound spectrum.
4. 4.Exploration of the correlation between subjective perception and objective assessment of snoring.
5. 5.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.
6. 6.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.
7. 7.Outcomes
8. 8.Development of snore sound spectrum in sleep-disorder breathing patients.
9. 9.Correlation of parameters between snore sound recording (loudness, frequency, count, regularity, etc ) and clinical parameters.
10. 10.Correlation between objective (snore sound analysis) and subjective (SOS,VAS) assessment of snoring.
11. 11.Comparison of changes in snoring (particular in objective assessment) after radiofrequency or pillar implant.
12. 12.Comparison of changes in snoring between radiofrequency and pillar implant.

Conditions

Primary Snoring; Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; snoring; radiofrequency; pillar implant; snore sound analysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Change in SOS Score After MIS

  baseline and 3 months following surgery

• Percent Change in Total-SI After MIS

  baseline and 3 months following surgery

• Percent Change in Total-Imax After MIS

  baseline and 3 months following surgery

• Percent Change in Total-Imean After MIS

  baseline and 3 months following surgery

• Percent Change in Total-Fpeak After MIS

  baseline and 3 months following surgery

Study Arms (2)

Pillar implant

EXPERIMENTAL

Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring.

Device: Pillar implant

Radiofrequency

ACTIVE COMPARATOR

Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring.

Device: Radiofrequency

Interventions

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.

Also known as: Pillar implant (Medtronic Inc., USA)

Pillar implant

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).

Also known as: Somnus® Model S2 (Gyrus-ACMI Corporation, USA)

Radiofrequency

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• moderate or severe obstructive sleep apnea
• pathological obesity
• significant craniofacial anomaly
• elderly
• unfavorable anatomic structure for minimal invasive surgery.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24816691 BACKGROUND

Related Links

• Chang Gung Memorial Hospital at Linkou is a tertiary medical center in Taiwan (R.O.C.).

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Hsueh-Yu Li
• Organization: Chang Gung Memorial Hospital

hyli38@adm.cgmh.org.tw

886-3-3281200

Study Officials

• Hsueh Yu Li, professor

  Chang Gung Memorial Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: October 7, 2013
• Study Start: August 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: August 18, 2014
• Results First Posted: August 18, 2014

Record last verified: 2013-10

Locations

TW (1)