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

This study is not yet open for participant recruitment.

Verified by Liaoyang Central Hospital, November 2006

Sponsored by:	Liaoyang Central Hospital
Information provided by:	Liaoyang Central Hospital
ClinicalTrials.gov Identifier:	NCT00399451

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 I Phase II

MedlinePlus related topics: Sleep Apnea Snoring

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)

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

None

More Information

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

Keywords provided by Liaoyang Central Hospital:

Sleep Apnea,Obstructive
apnea-hypopnea index (AHI)
polidocanol
sclerotherapy
pharynges

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Sounds
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Snoring
Sleep Disorders

Dyssomnias
Sclerosis
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Polidocanol
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:

Therapeutic Uses
Nervous System Diseases
Sclerosing Solutions
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009