NCT02078778

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:

  1. 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. 2.Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

March 1, 2014

Last Update Submit

January 30, 2015

Conditions

HypertensionObstructive Sleep Apnea

Keywords

Continuous airway pressureHypertensionObstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • Difference i central systolic BP

    3 months

  • Difference i BP throughout the day

    3 months

  • Correlation between degree of OSA and kidney function on effect of treatment

    3 months

  • urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)

    3 months

  • Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAPDEVICE

3 months of CPAP treatment

Also known as: S9 AutoSet frem ResMed/MAribo Medico, or, REMstar Auto A-Flex frem Phillips/Respirsonics
Treatment

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years
  • Signed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, 7500, Denmark

RECRUITING

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 1, 2014

First Posted

March 5, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

DK(1)