Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
Information source: Liaoyang Central Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Apnea; Snoring
Intervention: Polidocanol Sclerotherapy (Drug)
Phase: Phase 1/Phase 2
Status: Not yet recruiting
Sponsored by: Liaoyang Central Hospital Official(s) and/or principal investigator(s):
Youliang YIN, MB, Study Director
Overall contact:
Hongyan Chen, MB, Phone: +86-0419-3221423, Email: lychy2006@yahoo.com.cn
Summary
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of
pharynx for OSAS & SS,to reduce pharyngeal compliance.
Clinical Details
Official title: Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
Secondary outcome: Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- OSAS & SS which palatopharyngeal collapse.
Exclusion Criteria:
- obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow
result in.
Locations and Contacts
Hongyan Chen, MB, Phone: +86-0419-3221423, Email: lychy2006@yahoo.com.cn Additional Information
Starting date: December 2006
Last updated: November 20, 2006
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