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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by Liaoyang Central Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399451
First Posted: November 14, 2006
Last Update Posted: November 22, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Liaoyang Central Hospital
  Purpose
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS & SS,to reduce pharyngeal compliance.

Condition Intervention Phase
Apnea Snoring Drug: Polidocanol Sclerotherapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)

Resource links provided by NLM:


Further study details as provided by Liaoyang Central Hospital:

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

Estimated Enrollment: 30
Study Start Date: December 2006
Estimated Study Completion Date: June 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSAS & SS which palatopharyngeal collapse.

Exclusion Criteria:

  • obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399451


Contacts
Contact: Hongyan Chen, MB +86-0419-3221423 lychy2006@yahoo.com.cn

Sponsors and Collaborators
Liaoyang Central Hospital
Investigators
Study Director: Youliang YIN, MB
  More Information

ClinicalTrials.gov Identifier: NCT00399451     History of Changes
Other Study ID Numbers: LYZXYY06002
ACTRNO12606000444583
First Submitted: November 13, 2006
First Posted: November 14, 2006
Last Update Posted: November 22, 2006
Last Verified: November 2006

Keywords provided by Liaoyang Central Hospital:
Sleep Apnea,Obstructive
apnea-hypopnea index (AHI)
polidocanol
sclerotherapy
pharynges

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions


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