Back to resultsA Combined Surgical and Medical Approach in Mild Sleep Apnea
Primary Purpose
Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
acetazolamide
placebo
uvulopalatopharygoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, snoring, acetazolamide, uvulopalatopharyngoplasty, daytime sleepiness, upper airway
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- University Hospital AntwerpRecruiting
Outcomes
Primary Outcome Measures
Polysomnographic parameters
Secondary Outcome Measures
subjective sleepiness
subjective snoring
satisfaction
Full Information
NCT ID
NCT00497120
First Posted
July 4, 2007
Last Updated
July 5, 2007
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT00497120
Brief Title
A Combined Surgical and Medical Approach in Mild Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, snoring, acetazolamide, uvulopalatopharyngoplasty, daytime sleepiness, upper airway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Procedure
Intervention Name(s)
uvulopalatopharygoplasty
Primary Outcome Measure Information:
Title
Polysomnographic parameters
Secondary Outcome Measure Information:
Title
subjective sleepiness
Title
subjective snoring
Title
satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilfried De Backer, MD PhD
Phone
+32 3 821 34 47
Email
wilfried.debacker@ua.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried De Backer, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier M Vanderveken, MD
Email
olivier.vanderveken@uza.be
First Name & Middle Initial & Last Name & Degree
Olivier M Vanderveken, MD
First Name & Middle Initial & Last Name & Degree
Annick Devolder, MD
12. IPD Sharing Statement
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A Combined Surgical and Medical Approach in Mild Sleep Apnea
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