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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
Information provided by:
Liaoyang Central Hospital Identifier:
First received: November 13, 2006
Last updated: November 20, 2006
Last verified: November 2006
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.

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

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
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Please refer to this study by its identifier: NCT00399451

Contact: Hongyan Chen, MB +86-0419-3221423

Sponsors and Collaborators
Liaoyang Central Hospital
Study Director: Youliang YIN, MB
  More Information Identifier: NCT00399451     History of Changes
Other Study ID Numbers: LYZXYY06002
Study First Received: November 13, 2006
Last Updated: November 20, 2006

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

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Sclerosing Solutions
Pharmaceutical Solutions processed this record on September 21, 2017