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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00438412
Other study ID # MED.RES.HOS.2006.01.PHH
Secondary ID
Status Suspended
Phase Phase 4
First received February 20, 2007
Last updated April 17, 2008
Start date October 2006

Study information

Verified date April 2008
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Denmark Department of Medical Research, Holstebro Hospital Holstebro

Sponsors (1)

Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

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