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NCT00399451 Clinical Trial

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

Apnea Clinical Trial

Official title:
Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00399451
Other study ID # LYZXYY06002
Secondary ID ACTRNO1260600044
Status Not yet recruiting
Phase Phase 1/Phase 2
First received November 13, 2006
Last updated November 20, 2006
Start date December 2006
Est. completion date June 2009

Study information
Verified date November 2006
Source Liaoyang Central Hospital
Contact Hongyan Chen, MB
Phone +86-0419-3221423
Email lychy2006@yahoo.com.cn
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date June 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- OSAS & SS which palatopharyngeal collapse.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Polidocanol Sclerotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Liaoyang Central Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
Secondary Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
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