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Trial record 3 of 14 for:    Open Studies | "Snoring"
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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 because the information has not been verified recently.
Verified November 2006 by Liaoyang Central Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Liaoyang Central Hospital
ClinicalTrials.gov Identifier:
NCT00399451
First received: November 13, 2006
Last updated: November 20, 2006
Last verified: November 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Sleep Apnea Snoring
Drug Information available for: Polidocanol
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00399451     History of Changes
Other Study ID Numbers: LYZXYY06002, ACTRNO12606000444583
Study First Received: November 13, 2006
Last Updated: November 20, 2006
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Snoring
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds
Polidocanol
Sclerosing Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013