Polidocanol Sclerotherapy of Pharynges for Obstructive Sl... | NCT00399451

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

NCT00399451

Sponsor

Liaoyang Central Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2006Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Apnea
Snoring

Interventions

Polidocanol Sclerotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ACTRNO12606000444583

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Not provided

Completion Date

Jun 2009

First Submitted Date

Nov 13, 2006

First Submission Date that Met QC Criteria

Nov 13, 2006

First Posted Date

Nov 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2006

Last Update Posted Date

Nov 22, 2006Estimated

Description Module

Brief Summary

The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS & SS,to reduce pharyngeal compliance.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Polidocanol Sclerotherapy	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.

Secondary Outcomes

Measure	Description	Time Frame
Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

OSAS & SS which palatopharyngeal collapse.

Exclusion Criteria:

obstructive sleep apnea syndrome (osas) & snoring subjects (ss),which anatomic narrow result in.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongyan Chen, MB	Contact	+86-0419-3221423		lychy2006@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Youliang YIN, MB		Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea
D012913	Snoring
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided