Sleep ApneaNCT00497120
A Combined Surgical and Medical Approach in Mild Sleep Apnea
A study testing acetazolamide and uvulopalatopharygoplasty in people with Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- acetazolamide and uvulopalatopharygoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 5 ≤ Apnea Hypopnea Index (AHI) < 20
- Socially disturbing snoring: Visual Analogue Scale (VAS)snoring > 6/10
- Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP)
Who cannot join
- Previous surgical treatment for sleep-disordered breathing.
- Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS).
- Forced expiratory volume in 1 second (FEV1) < 80 % pred.
- Echocardiography: ejectionfraction < 35 % or dyastolic dysfunction grade 2 or more.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Antwerp
Edegem, Antwerp, 2650
Olivier M Vanderveken, MD, olivier.vanderveken@uza.be
Olivier M Vanderveken, MD
About this study
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.
- Conditions
- Sleep Apnea
- Being tested
- acetazolamide, placebo, uvulopalatopharygoplasty
- Keywords
- sleep apnea, snoring, acetazolamide, uvulopalatopharyngoplasty, daytime sleepiness, upper airway
- Medical subject headings
- Sleep Apnea Syndromes, Snoring, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetazolamideDrug
placeboDrug
uvulopalatopharygoplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic parameters
Secondary outcomes (3)
subjective sleepiness
subjective snoring
satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Investigators
- Wilfried De Backer, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497120
- Sponsor's protocol ID
- EC 2/27/99
- Status last verified
- Jul 2007
- First submitted
- 4 Jul 2007
- Last updated
- 6 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Surgical and Medical Approach in Mild Sleep Apnea
- ClinicalTrials.gov ID
- NCT00497120
- Acronym / sponsor ID
- EC 2/27/99
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, snoring, acetazolamide, uvulopalatopharyngoplasty, daytime sleepiness, upper airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 5 ≤ Apnea Hypopnea Index (AHI) < 20
- Socially disturbing snoring: Visual Analogue Scale (VAS)snoring > 6/10
- Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP)
Key exclusion criteria (4 listed)
- Previous surgical treatment for sleep-disordered breathing.
- Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS).
- Forced expiratory volume in 1 second (FEV1) < 80 % pred.
- Echocardiography: ejectionfraction < 35 % or dyastolic dysfunction grade 2 or more.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetazolamide | Drug | – |
| placebo | Drug | – |
| uvulopalatopharygoplasty | Procedure or surgery | – |
Primary outcome
Polysomnographic parameters
3 secondary outcomes
subjective sleepiness
subjective snoring
satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried De Backer, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetazolamide and uvulopalatopharygoplasty in people with Sleep Apnea, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfried De Backer, MD PhD (+32 3 821 34 47, wilfried.debacker@ua.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnographic parameters. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2007.