Back to resultsPolidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
Primary Purpose
Apnea, Snoring
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Polidocanol Sclerotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Apnea focused on measuring Sleep Apnea,Obstructive, apnea-hypopnea index (AHI), polidocanol, sclerotherapy, pharynges
Eligibility Criteria
Inclusion Criteria:
- OSAS & SS which palatopharyngeal collapse.
Exclusion Criteria:
- obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.
Sites / Locations
Outcomes
Primary Outcome Measures
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
Secondary Outcome Measures
Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
Full Information
NCT ID
NCT00399451
First Posted
November 13, 2006
Last Updated
November 20, 2006
Sponsor
Liaoyang Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00399451
Brief Title
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
Official Title
Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Liaoyang Central Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Snoring
Keywords
Sleep Apnea,Obstructive, apnea-hypopnea index (AHI), polidocanol, sclerotherapy, pharynges
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Polidocanol Sclerotherapy
Primary Outcome Measure Information:
Title
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.
Secondary Outcome Measure Information:
Title
Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OSAS & SS which palatopharyngeal collapse.
Exclusion Criteria:
obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyan Chen, MB
Phone
+86-0419-3221423
Email
lychy2006@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youliang YIN, MB
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
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