Obstructive Sleep ApneaNCT05742360
Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
An observational study of Obstructive Sleep Apnea, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP therapy
- Type of treatment
- Medical device
- How many people
- 227 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2023to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, 43221
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype
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.
Read the detailed description
This is a prospective, non-randomized, observational, two-center study involving newly diagnosed subjects with moderate-severe OSA with the excessively sleepy symptom subtype.
Variables of Interest: Change in 24-hour ambulatory BP, change in sitting BP, change in reaction time by psychomotor vigilance test (PVT)
Participants will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities. The blood samples will be used to determine levels of BP medications and serum creatinine. Measurements will be collected at baseline and at 6-month follow-up visits.
Data Analysis Approach: To correct for potential bias in the non-randomized comparison, the investigators will apply a Propensity Score (PS) Design via subclassification. Models to derive the PS values used in this design will include a number of covariates relevant to CPAP adherence, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, history of hypertension, diabetes mellitus (history, medications), lipid profile, hyperlipidemia (history, medications), family history of premature coronary disease, Charlson comorbidity index, physical activity (IPAQ), diet, OSA severity (AHI, ODI4, T90), sleepiness (Epworth Sleepiness Scale), educational attainment, socioeconomic status (postcode), insomnia symptoms (Insomnia Symptom Questionnaire), anxiety and depression-related symptoms (Patient Health Questionnaire-2), self-efficacy (General self-efficacy scale), and medication adherence (Medication Adherence Report Scale [MARS-5]). Baseline values of outcome measures will also be included in the PS model. After creating the PS design, all analyses are performed accounting for PS subclass as a categorical stratification factor. Evaluations of the CPAP effect on binary outcomes are performed utilizing conditional logistic regression. Similarly, CPAP effects in the context of survival analyses (e.g., Cox Proportional Hazards models) or on continuous outcomes (e.g., linear regression) are assessed by including PS subclass as a categorical covariate in all models.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP therapy
- Keywords
- Excessively Sleepy Symptom Subtype
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP therapyDevice
CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype
| Study group | Role | What they receive |
|---|---|---|
| OSA subjects with the excessively sleepy symptom subtype treated with CPAP | Patients with the excessively sleepy symptom subtype who accept CPAP therapy Receives: Device: CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour Mean Blood Pressure
24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
Measured: Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy
Secondary outcomes (2)
Nocturnal Mean BP
Nocturnal Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
Measured: Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy
Reciprocal of Reaction Time
Reciprocal of reaction time obtained by Psychomotor Vigilance Test
Measured: Change from baseline reaction time at 6-months after initiation of CPAP therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start7 Feb 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Ulysses Magalang MD, Ohio State University
- Investigators
- Ulysses Magalang, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742360
- Sponsor's protocol ID
- 2022H0323
- Status last verified
- Jul 2026
- First submitted
- 26 Jan 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype
- ClinicalTrials.gov ID
- NCT05742360
- Acronym / sponsor ID
- 2022H0323
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Excessively Sleepy Symptom Subtype
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, non-randomized, observational, two-center study involving newly diagnosed subjects with moderate-severe OSA with the excessively sleepy symptom subtype.
Variables of Interest: Change in 24-hour ambulatory BP, change in sitting BP, change in reaction time by psychomotor vigilance test (PVT)
Participants will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities. The blood samples will be used to determine levels of BP medications and serum creatinine. Measurements will be collected at baseline and at 6-month follow-up visits.
Data Analysis Approach: To correct for potential bias in the non-randomized comparison, the investigators will apply a Propensity Score (PS) Design via subclassification. Models to derive the PS values used in this design will include a number of covariates relevant to CPAP adherence, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, history of hypertension, diabetes mellitus (history, medications), lipid profile, hyperlipidemia (history, medications), family history of premature coronary disease, Charlson comorbidity index, physical activity (IPAQ), diet, OSA severity (AHI, ODI4, T90), sleepiness (Epworth Sleepiness Scale), educational attainment, socioeconomic status (postcode), insomnia symptoms (Insomnia Symptom Questionnaire), anxiety and depression-related symptoms (Patient Health Questionnaire-2), self-efficacy (General self-efficacy scale), and medication adherence (Medication Adherence Report Scale [MARS-5]). Baseline values of outcome measures will also be included in the PS model. After creating the PS design, all analyses are performed accounting for PS subclass as a categorical stratification factor. Evaluations of the CPAP effect on binary outcomes are performed utilizing conditional logistic regression. Similarly, CPAP effects in the context of survival analyses (e.g., Cox Proportional Hazards models) or on continuous outcomes (e.g., linear regression) are assessed by including PS subclass as a categorical covariate in all models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA subjects with the excessively sleepy symptom subtype treated with CPAP | – | Device: CPAP therapyPatients with the excessively sleepy symptom subtype who accept CPAP therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP therapyCPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype | Device | OSA subjects with the excessively sleepy symptom subtype treated with CPAP |
Primary outcome
Change in 24-hour Mean Blood Pressure
Time frame: Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy
24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
2 secondary outcomes
Nocturnal Mean BP
Time frame: Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy
Reciprocal of Reaction Time
Time frame: Change from baseline reaction time at 6-months after initiation of CPAP therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulysses Magalang, MD principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour Mean Blood Pressure (time frame: Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.