Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01044355
• Other study ID #: 09-038-SDR (SARHT 1001)
• Status: Active, not recruiting
• Phase: N/A
• First received: January 6, 2010
• Last updated: March 20, 2018
• Start date: December 2009
• Est. completion date: January 2020

Study information

• Verified date: March 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).

The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.

Description:

The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: January 2020
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Resistant Hypertension

• Moderate Obstructive Sleep Apnea

Exclusion Criteria:

• Creatinine >150 µmol/l

• Systolic blood pressure > 170 mmHg

• Diastolic blood pressure > 105 mmHg

• Secondary cause of hypertension other than OSA

• Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder

• Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Resistant Hypertension
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
6 weeks treatment with fixed CPAP
• APAP
6 weeks of treatment with auto-titrating positive airway pressure

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	OSR Medical Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour blood pressure.		6 weeks and 12 weeks after initial intervention
Secondary	Non-invasive measures of arterial stiffness using applanation tonometry.		6 weeks and 12 weeks after initial intervention
Secondary	Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.		6 weeks and 12 weeks after initial intervention
Secondary	Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.		6 weeks and 12 weeks after initial intervention