ApneaPhase 1/2NCT00399451
Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS)
A Phase 1/2 study testing Polidocanol Sclerotherapy in people with Apnea and Snoring, run by Liaoyang Central Hospital.
Trial summary
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \& SS,to reduce pharyngeal compliance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Polidocanol Sclerotherapy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2009
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSAS \& SS which palatopharyngeal collapse.
Who cannot join
- obstructive sleep apnea syndrome (osas) \& snoring subjects (ss),which anatomic narrow result in.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Preliminary Study on Submucous Sclerosis of Pharynges With 1% Polidocanol to Treat Obstructive Sleep Apnea (OSA) & Snoring Subjects (SS)
The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS \& SS,to reduce pharyngeal compliance.
Read the 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.
- Being tested
- Polidocanol Sclerotherapy
- Keywords
- Sleep Apnea,Obstructive, apnea-hypopnea index (AHI), polidocanol, sclerotherapy, pharynges
- Medical subject headings
- Apnea, Snoring, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol SclerotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startDec 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Liaoyang Central Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Youliang YIN, MB, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399451
- Sponsor's protocol ID
- LYZXYY06002
- Other IDs
- ACTRNO12606000444583
- Status last verified
- Nov 2006
- First submitted
- 13 Nov 2006
- Last updated
- 22 Nov 2006
- Results posted
- No