Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-75
SponsorOhio State University

About this trial

The primary objective of this study is to determine whether the effect of continuous positive airway pressure (CPAP) therapy on 24-hour mean blood pressure (BP) in patients with obstructive sleep apnea (OSA) varies between symptom phenotypes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

30 to 75 years of age

Among patients with hypertension, no change in BP medication for at least 3 months.

Willing and able to give informed consent

Willing and able to complete ambulatory blood pressure monitoring at baseline and after 6-months.

Disqualifiers

Unable to apply BP cuff (e.g. arm circumference >55 cm, prior breast cancer, structural abnormalities of the arm)

Current use of CPAP or Dental Device for OSA

Category III-IV of heart failure

Presence of Cheyne-Stokes Respiration (CSR) in PSG

Trial population

Adults between the ages of 30 to 75 years old with moderate to severe obstructive sleep apnea (OSA). OSA diagnosis will be defined as an apnea/hypopnea index (AHI) \>or =5 episodes per hour.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CPAP therapy

    Device

    CPAP treatment of obstructive sleep apnea.

Treatment groups

1,739 Participants
are divided into 1 treatment group
Group A: OSA Subjects Treated with CPAP1 intervention

Trial outcomes

Primary outcomes

1

24-hour Mean Blood Pressure

24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)

Time frame
Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.

Secondary outcomes

1

Heart Rate Variability

Heart Rate Variability obtained from 5-minute ECG

Time frame
Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

University of Pennsylvania

Collaborator

Chang Gung Memorial Hospital

Collaborator

University of Sydney

Collaborator

The University of Western Australia

Collaborator

Peking University

Collaborator

Ruijin Hospital

Collaborator

National University of Singapore

Collaborator

University of Iceland

Collaborator

Geisinger Health

Collaborator

Charite University, Berlin, Germany

Collaborator