Trial Outcomes & Findings for Analysis of Snore Sound Following Minimal Invasive Surgery in Sleep-disordered Breathing Patients (NCT NCT01955083)

NCT ID: NCT01955083

Last Updated: 2014-08-18

Results Overview

The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

baseline and 3 months following surgery

Results posted on

2014-08-18

Participant Flow

This study was a prospective, randomized, parallel-controlled trial in a tertiary medical center (Department of Otorhinolaryngology, Head and Neck Surgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan). Subjects were recruitment from October 1, 2010 to March 31, 2012.

The additional inclusion criteria were: a) length of the soft palate ≥ 2.5 cm and b) the width of the base of the uvular ≥ 1.0 cm. The exclusion criteria were: a) tonsillar hypertrophy; b) high tongue position; c) retrognathia; d) craniofacial abnormalities, e) trismus, f) allergy to anesthetic, and g) poorly controlled medical disorders.

Participant milestones

Participant milestones
Measure	Radiofrequency Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. 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).	Pillar Implant Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. 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.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiofrequency Arm 2- Radiofrequency (control group): 15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. 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).	Pillar Implant Arm 1- Pillar implant (Study group): 15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. 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.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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