RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes

Quick Facts

Study Start:2021-03-22

Study Completion:2032-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04712656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * Sleep study \[Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) performed based on clinical grounds * 4% oxygen desaturation index (ODI4) ≥15 events/hour on clinical sleep study * Planned CPAP treatment by treating provider	* 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 * Predominantly central sleep apnea (AHI≥15 events/hour) * Pregnancy * History of renal failure, or renal transplant * Self-reported sleep duration less than 5 hours per night on weeknights (work nights) * Other sleep disorders * Use of supplemental oxygen during wakefulness or sleep * Self-reported illicit drug use or marijuana use more than once per week * Unstable medical conditions: uncontrolled angina, uncontrolled hypertension, severe chronic obstructive pulmonary disease, active cancer, or unstable psychiatric disease * Any underlying condition that, in the opinion of the lead investigator, prohibits participation in the study * Development or adoption of any of the above exclusion criteria during the study period

Inclusion Criteria

Exclusion Criteria

* 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.
* Sleep study \[Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) performed based on clinical grounds
* 4% oxygen desaturation index (ODI4) ≥15 events/hour on clinical sleep study
* Planned CPAP treatment by treating provider

* 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
* Predominantly central sleep apnea (AHI≥15 events/hour)
* Pregnancy
* History of renal failure, or renal transplant
* Self-reported sleep duration less than 5 hours per night on weeknights (work nights)
* Other sleep disorders
* Use of supplemental oxygen during wakefulness or sleep
* Self-reported illicit drug use or marijuana use more than once per week
* Unstable medical conditions: uncontrolled angina, uncontrolled hypertension, severe chronic obstructive pulmonary disease, active cancer, or unstable psychiatric disease
* Any underlying condition that, in the opinion of the lead investigator, prohibits participation in the study
* Development or adoption of any of the above exclusion criteria during the study period

Contacts and Locations

Study Contact

ALICIA GONZALEZ ZACARIAS, MD

CONTACT

614-366-2361

Alicia.Gonzalezzacarias@osumc.edu

Principal Investigator

Ulysses Magalang, MD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

Martha Morehouse Medical Pavilion, Suite 2600

Columbus, Ohio, 43221

United States

Collaborators and Investigators

Sponsor: Ohio State University

Ulysses Magalang, MD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-22

Study Completion Date2032-03-01

Study Record Updates

Study Start Date2021-03-22

Study Completion Date2032-03-01

Terms related to this study

Keywords Provided by Researchers

Cardiovascular

Additional Relevant MeSH Terms

Sleep Apnea, Obstructive