RECRUITING

Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype

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Conditions

Obstructive Sleep ApneaExcessively Sleepy Symptom Subtype

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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 the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.

Official Title

Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype

Quick Facts

Study Start:2023-02-07
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05742360

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:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-75 years
  2. * Moderate-severe OSA (defined as ODI ≥10 events/hour) via Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) done based on clinical grounds
  3. * Excessively sleepy subtype determined by patient-reported symptoms
  4. * Willing to accept CPAP therapy
  5. * An elevated baseline office BP defined as ≥120 or ≥80 mmHg
  6. * Planned PAP (CPAP or bi-level PAP) treatment by treating provider
  1. * Recent changes (within 3 months) to BP medications among those who are on these medications
  2. * Unable to apply ABPM cuff
  3. * Current use of CPAP or other OSA treatments
  4. * Resting, awake SaO2 \<90% or use of home oxygen therapy
  5. * New York Heart Association (NYHA) categories III-IV of heart failure
  6. * Presence of Cheyne-Stokes Respiration (CSR) in sleep study identified by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation
  7. * Predominantly central sleep apnea (AHI≥15 events/hour, with \>50% central events \[apnea or hypopnea\])
  8. * Life expectancy \<2 years
  9. * Pregnancy
  10. * Clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
  11. * Systolic BP \> 180 mmHg

Contacts and Locations

Study Contact

Alicia Gonzalez Zacarias, MD
CONTACT
6143662361
alicia.gonzalezzacarias@osumc.edu
Joseph Santiago, RRT
CONTACT
6143664756
joseph.santiago@osumc.edu

Principal Investigator

Ulysses Magalang, MD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, 43221
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
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 Date2023-02-07
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2023-02-07
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • Excessively Sleepy Symptom Subtype

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea