Central and Peripheral Blood Pressure in Treatment of Obs... | NCT02078778

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

NCT02078778

Sponsor

Erling Bjerregaard Pedersen

Status

Unknown status

Last Update Posted

Feb 2, 2015Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Hypertension
Obstructive Sleep Apnea

Interventions

CPAP

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

ID	Type	Description	Link
M-2013-304-13	Other Identifier	The Regional Committee of Health Research Ethics

Status Module

Record Verification Date

Jan 2015

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

Feb 2014

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Mar 1, 2014

First Submission Date that Met QC Criteria

Mar 1, 2014

First Posted Date

Mar 5, 2014Estimated

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

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erling Bjerregaard Pedersen, professor, Regional Hospital HolstebroSponsor-Investigator

Lead Sponsor

Erling Bjerregaard PedersenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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:

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.
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

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.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months.	Device: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP	Device	3 months of CPAP treatment	Treatment	S9 AutoSet frem ResMed/MAribo Medico

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference in systolic peripheral BP at night	The difference in systolic BP at night by peripheral BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Difference i central systolic BP	The difference in systolic BP at night in central BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.	3 months
Difference i BP throughout the day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012891	Sleep Apnea Syndromes
D001049	Apnea

Browse Leaves

Not provided

Browse Branches

Not provided

The difference in systolic BP and diastolic BP throughout the day, in the daytime and in nighttime between measurements with peripheral and central 24-h blood pressure monitoring before and after 3 months of treatment with CPAP.