Central and Peripheral 24-h Blood Pressure Before and After 3 Month of CPAP Treatment in Obstructive Sleep Apnea

NCT01951248 | Unknown

• 2 other identifiers: BGH-3-2013M-2013-285-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of 3 months of continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) in moderate to severe cases in patients with chronic kidney disease. The effect is evaluated on blood pressure levels, particularly nocturnal blood pressure, both central and peripheral, and renal function, including the kidneys treatment of salt and water. Hypothesis:

1. 1.Central 24-h blood pressure measuring is a reveals fluctuations in blood pressure during the day more accurately than peripheral 24-h blood pressure measuring because the measurement is painless and does not interfere with the patient activities during the daytime or nighttime sleep.
2. 2.Central blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
3. 3.The renal tubular function relating to the treatment of water and sodium is abnormal in patients with OSA with increased tubular absorption of water via the U-aquaporin 2 (u-AQP2) and of sodium by epithelial sodium channel (ENAC) and is normalized during treatment with CPAP.

Conditions

Chronic Kidney Disease; Obstructive Sleep Apnea

Keywords

chronic kidney disease; obstructive sleep apnea; 24-h blood pressure; central blood pressure; peripheral blood pressure

Outcome Measures

Primary Outcomes (1)

• decrease in systolic night time blood pressure

  The difference in systolic blood pressure at night by 24-h blood pressure at baseline and 3 months of treatment of OSA with CPAP in patients with chronic renal insufficiency.

  3 months

Secondary Outcomes (5)

• difference in systolic blood pressure at night by central blood pressure monitoring

  3 months

• systolic and diastolic blood pressure throughout the day

  3 months

• correlation between blood pressure, OSA and kidney function

  3 months

• U-AQP2 and u-ENaCɣ in day urine. PRC, p-AngII, p-Aldo. P-AVP and p-endothelial.

  3 months

• quality af life

  3 months

Study Arms (1)

CPAP treatment

EXPERIMENTAL

Patients with chronic kidney disease and moderate to severe obstructive sleep apnea is treated 3 months with CPAP treatment

Device: CPAP - continuous airway pressure

Interventions

CPAP - continuous airway pressure DEVICE

3 months of treatment with CPAP treatment

Also known as: S9 AutoSet from ResMed/Maribo Medico, or, REMstar Auto A-Flex from Phillips/Respirsonics

CPAP treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• renal insufficiency (CKD stage III + IV), estimated glomerular filtration rate (eGFR) 15-59 ml/min/1.73 m2
• Obstructive sleep apnea, AHI\> 15 (moderate to severe)
• both men and women
• years

You may not qualify if:

• lack of desire to participate
• malignant disease
• Abuse of drugs or alcohol
• pregnant and lactating
• incompensated heart failure
• atrial fibrillation
• liver disease (alanine aminotransferase\> 200)
• Severe chronic obstructive lung disease (Forced expiratory volume in 1 second \<50% predicted)

Sponsors & Collaborators

• Erling Bjerregaard Pedersen: lead

Study Sites (1)

Medicinsk Forskning

Holstebro, Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

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: September 23, 2013
• First Posted: September 26, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

DK (1)