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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| Partners HealthCare | OTHER |
| Johns Hopkins University | OTHER |
| VA Boston Healthcare System |
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This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
This is a Phase II randomized controlled trial that will evaluate the effects of supplemental nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on patients with moderate to severe OSA but only mild OSA symptoms.
Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep apnea or snoring. Participants will be contributing to medical knowledge about different options that can be used to improve heart disease in people with sleep apnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLSE plus PAP | Other |
| |
| HLSE plus Oxygen | Other |
| |
| Healthy Lifestyles and Sleep Education | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Lifestyles and Sleep Education plus PAP | Other | Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including: |
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including: |
| 3 months |
| Compare nocturnal supplemental oxygen and PAP on measures of: |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Redline, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States | ||
| Partners HealthCare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41424523 | Derived | Hilmisson H, Thomas RJ, Magnusdottir S. Cardiopulmonary coupling-calculated sleep stability and nocturnal heart rate kinetics as a potential indicator for cardiovascular health: a relationship with blood pressure dipping. Front Sleep. 2024 Aug 1;3:1230958. doi: 10.3389/frsle.2024.1230958. eCollection 2024. | |
| 38507976 | Derived | Ni YN, Lei F, Tang X, Liang Z, Thomas RJ. The association between the effective apnea-hypopnea index and blood pressure reduction efficacy following CPAP/oxygen treatment. Sleep Med. 2024 May;117:46-52. doi: 10.1016/j.sleep.2024.02.046. Epub 2024 Mar 13. |
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| FED |
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|
| Healthy Lifestyles and Sleep Education plus Supplemental Oxygen | Other | Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. |
|
| Healthy Lifestyles and Sleep Education | Other | Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines. |
|
| 3 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| VA Boston Healthcare System | Boston | Massachusetts | 02132 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| 37938917 | Derived | Schmickl CN, Orr JE, Sands SA, Alex RM, Azarbarzin A, McGinnis L, White S, Mazzotti DR, Nokes B, Owens RL, Gottlieb DJ, Malhotra A. Loop Gain as a Predictor of Blood Pressure Response in Patients Treated for Obstructive Sleep Apnea: Secondary Analysis of a Clinical Trial. Ann Am Thorac Soc. 2024 Feb;21(2):296-307. doi: 10.1513/AnnalsATS.202305-437OC. |
| 34225174 | Derived | Magnusdottir S, Thomas RJ, Hilmisson H. Can improvements in sleep quality positively affect serum adiponectin-levels in patients with obstructive sleep apnea? Sleep Med. 2021 Aug;84:324-333. doi: 10.1016/j.sleep.2021.05.032. Epub 2021 May 29. |
| 32649638 | Derived | Magnusdottir S, Hilmisson H, Thomas RJ. Cardiopulmonary coupling-derived sleep quality is associated with improvements in blood pressure in patients with obstructive sleep apnea at high-cardiovascular risk. J Hypertens. 2020 Nov;38(11):2287-2294. doi: 10.1097/HJH.0000000000002553. |
| 24918372 | Derived | Gottlieb DJ, Punjabi NM, Mehra R, Patel SR, Quan SF, Babineau DC, Tracy RP, Rueschman M, Blumenthal RS, Lewis EF, Bhatt DL, Redline S. CPAP versus oxygen in obstructive sleep apnea. N Engl J Med. 2014 Jun 12;370(24):2276-85. doi: 10.1056/NEJMoa1306766. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D020181 | Sleep Apnea, Obstructive |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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