Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.

NCT ID: NCT02078778

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study is to examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA).

Hypothesis:

1. Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure more accurately than peripheral 24-h BP monitoring, because the measurement is painless and does not interfere with the patient / subject's activities during the daytime or nighttime sleep.
2. Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.

3\. The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.

4\. Quality of life improves during treatment with CPAP

Detailed Description

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Approximately 20 patients with hypertension and moderate to severe OSA are treated with CPAP 3 months to examine the treatment effect on blood pressure throughout the day, but especially nocturnal, renal treatment of salt and water, and quality of life.

Before and after 3 months of CPAP treatment is made central and peripheral 24-h ambulatory blood pressure monitoring, 24-h urine collection and blood samples.

Conditions

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Hypertension Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

3 months of CPAP treatment

Interventions

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CPAP

3 months of CPAP treatment

Intervention Type DEVICE

Other Intervention Names

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S9 AutoSet frem ResMed/MAribo Medico or REMstar Auto A-Flex frem Phillips/Respirsonics

Eligibility Criteria

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Inclusion Criteria

* chronic kidney disease (CKD stage I and II), eGFR 60-90 ml/min/1.73 m2 or eGFR\> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
* Obstructive sleep apnea, apnea hypopnea index (AHI) \> 15 (moderate to severe)
* Both men and women
* 55-70 years
* Signed consent form

Exclusion Criteria

* Lack of desire to participate
* Malignant disease
* Abuse of drugs or alcohol
* Pregnant and breastfeeding
* Incompensated heart failure
* Atrial fibrillation
* Liver disease (Alanine aminotransferase (ALT) \> 200)
* Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second \<50% predicted)
* Blood pressure difference between the right and left arm\> 10/10 mmHg
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erling Bjerregaard Pedersen

OTHER

Sponsor Role lead

Responsible Party

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Erling Bjerregaard Pedersen

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Bodil Gade Hornstrup, MD

Role: primary

+4578436587

Other Identifiers

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M-2013-304-13

Identifier Type: OTHER

Identifier Source: secondary_id

BGH-4-2013

Identifier Type: -

Identifier Source: org_study_id

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