Clinical trial NCT01086800: Heart Biomarker Evaluation in Apnea Treatment
Official title: Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Obstructive Sleep Apnea
Coronary Artery Disease
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Partners HealthCare
name: Johns Hopkins University
name: VA Boston Healthcare System
First posted: 2010-03-15
Enrollment: 318
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* established Coronary Artery Disease or established cardiovascular disease risk factors
* home sleep test that showed moderately severe sleep apnea

Exclusion Criteria:

* poorly controlled health
* currently using supplemental oxygen or PAP for OSA

Primary outcomes:
measure: To compare the effects of nocturnal supplemental oxygen and PAP versus optimized medical management on biomarkers of cardiovascular risk, including:
timeFrame: 3 months
Secondary outcomes:
measure: Compare the effects of nocturnal supplemental oxygen and PAP versus standard care on patient-reported outcomes, including:
timeFrame: 3 months
measure: Compare nocturnal supplemental oxygen and PAP on measures of:
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Partners HealthCare
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Brigham and Women's Hospital
name: Susan Redline, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.