Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000444583
Ethics application status
Approved
Date submitted
15/07/2006
Date registered
17/10/2006
Date last updated
17/10/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Polidocanol sclerotherapy of pharyngx for obstructive sleep apnea (OSA) and snoring subjects(SS)
Scientific title
Preliminary study on submucosous sclerosis of pharyngx with 1% polidocanol to treat obstructive sleep apnea (OSA) & snoring subjects (SS)
Universal Trial Number (UTN)
Trial acronym
PSP-osas & ss
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea syndrome (OSAS) 1416 0
Snoring subjects (SS) 1417 0
Condition category
Condition code
Respiratory 1513 1513 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Polysomnography (PSG) and 1% Polidocanol--submucosous sclerosis in the part of pharyngx with 1% polidocanol injection
The duration : about 4~5 years
Each patient with OSAS will be followed up 2 years after treatment.
The injection administered is during the treatment, the injection should be in the retrophargngeal 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 times.
-------The duration of the study is 4~5 years.the treatment is only during 1~3 months.The follow-up-2-year is carried on polysomnography and clinical study-observarion.
Intervention code [1] 1204 0
Treatment: Other
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2090 0
Apnea-hypopnea index (AHI) in 2 years.

AHI is on polysomnography (PSG), to compare AHI anterior (1 time) and posterior treatment (3 times).
Timepoint [1] 2090 0
Each patient with osas must be carried out PSG for 4 times.One time is before treatment, the others times are in 1/2, 1 and 2 years after treatment.
Primary outcome [2] 2091 0
Anterior-posterior treatment in 2 years.

AHI is on polysomnography (PSG), to compare AHI anterior (1 time) and posterior treatment (3 times).
Timepoint [2] 2091 0
Each patient with osas must be carried out PSG for 4 times.One time is before treatment, the others times are in 1/2, 1 and 2 years after treatment.
Secondary outcome [1] 3605 0
Arterial oxygen saturation (SaO2) and body mass index (BMI) will be measured on polysomnography (PSG), to compare the lowest SaO2 of anterior - posterior treatment and variation of BMI.
Timepoint [1] 3605 0

Eligibility
Key inclusion criteria
OSAS & ,SS which palatopharyngeal collapse.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obstructive sleep apnea syndrom (OSAS) & snoring subjects (SS),which anatomic narrow result.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 377 0
China
State/province [1] 377 0

Funding & Sponsors
Funding source category [1] 1648 0
Hospital
Name [1] 1648 0
Liaoyang central Hospital
Country [1] 1648 0
China
Primary sponsor type
Individual
Name
Youliang Yin
Address
Country
Secondary sponsor category [1] 1457 0
Hospital
Name [1] 1457 0
Liaoyang Central Hospital
Address [1] 1457 0
Country [1] 1457 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3099 0
Liaoyang Central hospital ethics committee
Ethics committee address [1] 3099 0
Ethics committee country [1] 3099 0
China
Date submitted for ethics approval [1] 3099 0
Approval date [1] 3099 0
28/06/2006
Ethics approval number [1] 3099 0
06002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36326 0
Address 36326 0
Country 36326 0
Phone 36326 0
Fax 36326 0
Email 36326 0
Contact person for public queries
Name 10393 0
Hongyan Chen
Address 10393 0
Emergency Department
Liaoyang Central Hospital
No.148 Zhonghua Street
Liaoyang Liaoning of PRC
111000
Country 10393 0
China
Phone 10393 0
0419 3221423
Fax 10393 0
Email 10393 0
[email protected] and [email protected]
Contact person for scientific queries
Name 1321 0
Youliang Yin
Address 1321 0
Ear-Nose-Throat Department
Liaoning Liaoyang Central Hospital
No.148 Zhonghua Street
111000 China
Country 1321 0
China
Phone 1321 0
0419 3220220 & 3220627
Fax 1321 0
Email 1321 0
[email protected] and [email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.