NCT00360659

Brief Summary

We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2006

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

First QC Date

August 3, 2006

Last Update Submit

April 17, 2008

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep ApneaHypertensionVasoactive hormones

Interventions

Continuous Positive Airway PressureDEVICE

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20 and 65 years
  • Obstructive sleep apnea
  • Hypertension or normal blood pressure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Holstebro Hospital

Holstebro, Ringkoebing County, 7500, Denmark

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Erling B Pedersen, Professor

    Regional Hospital Holstebro

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 4, 2006

Study Start

February 1, 2004

Study Completion

February 1, 2005

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

DK(1)