A Combined Surgical and Medical Approach in Mild Sleep Apnea | NCT00497120

Studies
A Combined Surgical and Medical Approach in Mild Sleep Apnea

NCT00497120

Sponsor

University Hospital, Antwerp

Status

Unknown status

Last Update Posted

Jul 6, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Sleep Apnea

Interventions

acetazolamide
placebo
uvulopalatopharygoplasty

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 4, 2007

First Submission Date that Met QC Criteria

Jul 5, 2007

First Posted Date

Jul 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2007

Last Update Posted Date

Jul 6, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Measure	Description	Time Frame
Polysomnographic parameters

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wilfried De Backer, MD PhD	Contact	+32 3 821 34 47		wilfried.debacker@ua.ac.be

Overall Officials

Name	Affiliation	Role
Wilfried De Backer, MD, PhD	University Hospital, Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Antwerp	Recruiting	Edegem	Antwerp	2650	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D012913	Snoring
D006970	Disorders of Excessive Somnolence

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000086	Acetazolamide

Ancestor Terms

ID	Term
D013830	Thiadiazoles
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
acetazolamide	Drug
placebo	Drug
uvulopalatopharygoplasty	Procedure

Measure	Description	Time Frame
subjective sleepiness
subjective snoring
satisfaction