Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2010-02-28
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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HLSE plus PAP
Healthy Lifestyles and Sleep Education plus PAP
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.
HLSE plus Oxygen
Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
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
Healthy Lifestyles and Sleep Education
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.
Interventions
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Healthy Lifestyles and Sleep Education plus PAP
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.
Healthy Lifestyles and Sleep Education plus Supplemental Oxygen
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
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.
Eligibility Criteria
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Inclusion Criteria
* home sleep test that showed moderately severe sleep apnea
Exclusion Criteria
* currently using supplemental oxygen or PAP for OSA
45 Years
75 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
Partners HealthCare
OTHER
Johns Hopkins University
OTHER
VA Boston Healthcare System
FED
Brigham and Women's Hospital
OTHER
Responsible Party
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Susan Redline
Senior Physician, Division of Sleep Medicine
Principal Investigators
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Susan Redline, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Partners HealthCare
Boston, Massachusetts, United States
VA Boston Healthcare System
Boston, Massachusetts, United States
Case Western Reserve University
Cleveland, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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