NCT00399451

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 22, 2006

Status Verified

November 1, 2006

First QC Date

November 13, 2006

Last Update Submit

November 20, 2006

Conditions

ApneaSnoring

Keywords

Sleep Apnea,Obstructiveapnea-hypopnea index (AHI)polidocanolsclerotherapypharynges

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index (AHI)is on polysomnography(PSG),to compare AHIanterior and posterior treatment.

Secondary Outcomes (1)

  • Arterial oxygen saturation (SaO2) and body mass index (BMI)will be measured on polysomnography

Interventions

Polidocanol SclerotherapyDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OSAS \& SS which palatopharyngeal collapse.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ApneaSnoringSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory SoundsSleep Apnea SyndromesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Youliang YIN, MB

    STUDY DIRECTOR

Central Study Contacts

Hongyan Chen, MB

CONTACT

+86-0419-3221423lychy2006@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

December 1, 2006

Study Completion

June 1, 2009

Last Updated

November 22, 2006

Record last verified: 2006-11