Sleep Apnea, ObstructiveNCT04712656
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP therapy
- Type of treatment
- Medical device
- How many people
- 1,739 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 1 Mar 2032
- How long will I take part?
- 10 Years
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, 43221
About this study
Official title: Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes
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.
Read the detailed description
This is a prospective, non-randomized, multi-center, cohort study involving patients with moderate to severe OSA. This study will compare OSA patients who accept and comply with CPAP therapy versus those who do not.
Variables of Interest: 24-hour ambulatory BP, sitting BP, electrocardiogram (ECG), facial photographs, psychomotor vigilance test (PVT), questionnaires, and blood samples.
Patients will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities associated with CVD. The blood samples will be used to look for evidence of diabetes; elevated lipids; markers of heart injury, inflammation, and coagulation; and genetic information. Measurements will be collected at baseline and at 6-month follow-up.
In addition, patients enrolled in this study will be contacted by telephone once a year over a ten year period. The purpose of the telephone interview is to determine if they are using any treatment for OSA, if they have developed any new health problems such as a heart attack or stroke, and if they have changed any of their usual medications.
Data Analysis Approach: To correct for potential bias in the non-randomized comparison, we 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 and cardiovascular outcomes, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, prevalent CVD at baseline, history of hypertension, HbA1c, 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
- Sleep Apnea, Obstructive
- Being tested
- CPAP therapy
- Keywords
- Cardiovascular
- 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.
| Study group | Role | What they receive |
|---|---|---|
| OSA Subjects Treated with CPAP | Patients with moderate to severe OSA (ODI4>15/h) 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.
24-hour Mean Blood Pressure
24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
Measured: 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
Measured: Measurements will be conducted at baseline (prior to CPAP therapy) and 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 posted15 Jan 2021
- Study start22 Mar 2021
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- 1,739 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Chang Gung Memorial Hospital, University of Sydney, The University of Western Australia, Peking University, Ruijin Hospital, National University of Singapore, University of Iceland, Geisinger Health, Charite University, Berlin, Germany
- 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
- NCT04712656
- Sponsor's protocol ID
- 2020H0524
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes
- ClinicalTrials.gov ID
- NCT04712656
- Acronym / sponsor ID
- 2020H0524
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Cardiovascular
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,739 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Chang Gung Memorial Hospital, University of Sydney, The University of Western Australia, Peking University, Ruijin Hospital, National University of Singapore, University of Iceland, Geisinger Health, Charite University, Berlin, Germany
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 15 Jan 2021 (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 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.
Detailed description
This is a prospective, non-randomized, multi-center, cohort study involving patients with moderate to severe OSA. This study will compare OSA patients who accept and comply with CPAP therapy versus those who do not.
Variables of Interest: 24-hour ambulatory BP, sitting BP, electrocardiogram (ECG), facial photographs, psychomotor vigilance test (PVT), questionnaires, and blood samples.
Patients will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities associated with CVD. The blood samples will be used to look for evidence of diabetes; elevated lipids; markers of heart injury, inflammation, and coagulation; and genetic information. Measurements will be collected at baseline and at 6-month follow-up.
In addition, patients enrolled in this study will be contacted by telephone once a year over a ten year period. The purpose of the telephone interview is to determine if they are using any treatment for OSA, if they have developed any new health problems such as a heart attack or stroke, and if they have changed any of their usual medications.
Data Analysis Approach: To correct for potential bias in the non-randomized comparison, we 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 and cardiovascular outcomes, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, prevalent CVD at baseline, history of hypertension, HbA1c, 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
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA Subjects Treated with CPAP | – | Device: CPAP therapyPatients with moderate to severe OSA (ODI4>15/h) who accept CPAP therapy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
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. | Device | OSA Subjects Treated with CPAP |
Primary outcome
24-hour Mean Blood Pressure
Time frame: Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.
24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
1 secondary outcome
Heart Rate Variability
Time frame: Measurements will be conducted at baseline (prior to CPAP therapy) and 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 16 Oct 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Ohio State University at 1 site 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 7 inclusion and 14 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
24-hour Mean Blood Pressure (time frame: Measurements will be conducted at baseline (prior to CPAP therapy) and 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 16 Oct 2026.