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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00497120
Other study ID # EC 2/27/99
Secondary ID
Status Recruiting
Phase N/A
First received July 4, 2007
Last updated July 5, 2007

Study information

Verified date July 2007
Source University Hospital, Antwerp
Contact Wilfried De Backer, MD PhD
Phone +32 3 821 34 47
Email wilfried.debacker@ua.ac.be
Is FDA regulated No
Health authority Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
acetazolamide

placebo

Procedure:
uvulopalatopharygoplasty


Locations

Country Name City State
Belgium University Hospital Antwerp Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Polysomnographic parameters
Secondary subjective sleepiness
Secondary subjective snoring
Secondary satisfaction
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