Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)

Phase 1

• Conditions: Apnea; Snoring

• Registration Number: NCT00399451
• Lead Sponsor: Liaoyang Central Hospital

Brief Summary

The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \& SS,to reduce pharyngeal compliance.

Detailed Description

Polidocanol submucous sclerosis in the part of pharynges with 1% polidocanol injection.The injection should be in the retropharyngeal submucosa and lateral pharyngeal bands and lateral pharyngeal submucosa and in front submucosa of soft palate.The injection is multi-point,and each point injection is 0.3\~0.5ml;the total quantity/each time is not more than 5ml.Every patient have to be treated about 1\~2 time.

Study Timeline

• Status Verified: 2006-11
• Study First Submitted: 2006-11-13
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Last Update Submitted: 2006-11-20
• Last Update Posted: 2006-11-22
• Study Start: 2006-12
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• OSAS & SS which palatopharyngeal collapse.

Exclusion Criteria

• obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.

Secondary Outcome Measures

Name	Time	Method
Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography