Vasoactive Hormones and Oxygen Saturation During Apneic E... | NCT00438412

Studies
Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea

NCT00438412

Sponsor

Regional Hospital Holstebro

Status

Suspended

Last Update Posted

Apr 22, 2008Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Not provided

Countries

Denmark

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

Apr 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

It was not possible to recruit enough patients with obstructive sleep apnea.

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 22, 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

Apr 17, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Description Module

Brief Summary

The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified.

We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Eligibility Module

Eligibility Criteria

Patients with Obstructive sleep apnea

Inclusion Criteria:

Severe obstructive sleep apnea (apnea-hypopnea index > 30)

Exclusion Criteria:

Drug or alcohol abuse
Pregnancy
History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
Diabetes

Healthy Controls

Inclusion Criteria:

Apnea-hypopnea index < 10

Exclusion criteria:

Drug or alcohol abuse
Pregnancy
History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
Diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Adults, males and females,age 30 -65

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, Professor	Regional Hospital Holstebro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research, Holstebro Hospital		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D003919	Diabetes Insipidus
D001049	Apnea

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided