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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 30, 2014