NCT05742360

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Feb 2023Mar 2028

First Submitted

Initial submission to the registry

January 26, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

January 26, 2023

Last Update Submit

August 8, 2025

Conditions

Obstructive Sleep Apnea

Keywords

Excessively Sleepy Symptom Subtype

Outcome Measures

Primary Outcomes (1)

  • Change in 24-hour Mean Blood Pressure

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

    Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy

Secondary Outcomes (2)

  • Nocturnal Mean BP

    Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy

  • Reciprocal of Reaction Time

    Change from baseline reaction time at 6-months after initiation of CPAP therapy

Study Arms (1)

OSA subjects with the excessively sleepy symptom subtype treated with CPAP

Patients with the excessively sleepy symptom subtype who accept CPAP therapy

Device: CPAP therapy

Interventions

CPAP therapyDEVICE

CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype

OSA subjects with the excessively sleepy symptom subtype treated with CPAP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults between the ages of 18 to 75 years old with moderate-severe obstructive sleep apnea (OSA) with excessively sleepy symptom subtype. OSA diagnosis will be defined as an apnea/hypopnea index (AHI) \>or =5 episodes per hour.

You may qualify if:

  • Age 18-75 years
  • Moderate-severe OSA (defined as ODI ≥10 events/hour) via Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) done based on clinical grounds
  • Excessively sleepy subtype determined by patient-reported symptoms
  • Willing to accept CPAP therapy
  • An elevated baseline office BP defined as ≥120 or ≥80 mmHg
  • Planned PAP (CPAP or bi-level PAP) treatment by treating provider

You may not qualify if:

  • Recent changes (within 3 months) to BP medications among those who are on these medications
  • Unable to apply ABPM cuff
  • Current use of CPAP or other OSA treatments
  • Resting, awake SaO2 \<90% or use of home oxygen therapy
  • New York Heart Association (NYHA) categories III-IV of heart failure
  • 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
  • Predominantly central sleep apnea (AHI≥15 events/hour, with \>50% central events \[apnea or hypopnea\])
  • Life expectancy \<2 years
  • Pregnancy
  • Clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
  • Systolic BP \> 180 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600

Columbus, Ohio, 43221, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The blood samples will be used to determine levels of BP medications and serum creatinine

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Ulysses Magalang, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Gonzalez Zacarias, MD

CONTACT

6143662361alicia.gonzalezzacarias@osumc.edu

Joseph Santiago, RRT

CONTACT

6143664756joseph.santiago@osumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 24, 2023

Study Start

February 7, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)