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

E

Erling Bjerregaard Pedersen

Status

Unknown

Conditions

Hypertension
Obstructive Sleep Apnea

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT02078778
BGH-4-2013
M-2013-304-13 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

55 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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