NCT00497120

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

July 4, 2007

Last Update Submit

July 5, 2007

Conditions

Sleep Apnea

Keywords

sleep apneasnoringacetazolamideuvulopalatopharyngoplastydaytime sleepinessupper airway

Outcome Measures

Primary Outcomes (1)

  • Polysomnographic parameters

Secondary Outcomes (3)

  • subjective sleepiness

  • subjective snoring

  • satisfaction

Interventions

acetazolamideDRUG
placeboDRUG
uvulopalatopharygoplastyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoringDisorders of Excessive Somnolence

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wilfried De Backer, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilfried De Backer, MD PhD

CONTACT

+32 3 821 34 47wilfried.debacker@ua.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 4, 2007

First Posted

July 6, 2007

Last Updated

July 6, 2007

Record last verified: 2007-07

Locations

BE(1)