- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399451
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
November 20, 2006 updated by: Liaoyang Central Hospital
Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS & SS,to reduce pharyngeal compliance.
Study Overview
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 Type
Interventional
Enrollment
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hongyan Chen, MB
- Phone Number: +86-0419-3221423
- Email: lychy2006@yahoo.com.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- OSAS & SS which palatopharyngeal collapse.
Exclusion Criteria:
- obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
|
Secondary Outcome Measures
Outcome Measure |
---|
Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Youliang YIN, MB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Study Completion
June 1, 2009
Study Registration Dates
First Submitted
November 13, 2006
First Submitted That Met QC Criteria
November 13, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Estimate)
November 22, 2006
Last Update Submitted That Met QC Criteria
November 20, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Respiratory Sounds
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Snoring
- Pharmaceutical Solutions
- Sclerosing Solutions
- Polidocanol
Other Study ID Numbers
- LYZXYY06002
- ACTRNO12606000444583
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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