N/A
N=169
Sleep Apnea Intervention for Cardiovascular Disease Reduction
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01261390 ↗Enrolled (actual)
169
Serious AEs
10.7%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms — 1.82; 1.06; 0.59; -0.73 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conservative Medical Therapy (CMT) (Behavioral); Sham PAP (Sham) (Device); Active PAP with RT Support (Active-Beh) (Device); Active PAP with Behavioral Modification (Active+Beh) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 by Pooled Arms |
1.82; 1.06; 0.59; -0.73; 1.00; -0.14 | — |
| PRIMARY Difference in CPAP Adherence by Active Treatment Arm |
3.3; 4.4 | 0.003 sig |
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Months 6 and 12 (4 Arms) |
1.69; 1.96; 1.30; 0.80; 0.43; 0.77 | — |
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Month 12 by Pooled Arms |
0.37; 0.17; -0.22; -1.57; -0.03; -0.99 | — |
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Month 6 by Pooled Arms |
2.60; 1.24; 0.97; -0.53; 1.52; 0.06 | — |
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Month 12 (4 Arms) |
-0.97; 2.22; -0.09; 0.45; -0.68; 0.40 | — |
| PRIMARY Change From Baseline in 24-hour Blood Pressure at Month 6 (4 Arms) |
2.45; 2.77; 2.12; 0.29; 0.85; 1.11 | — |
| SECONDARY Change in 36-Item Short Form Survey (SF-36) Measures (4 Arm) |
-1.3; -1.3; 1.1; 1.8; 0.6; 2.9 | — |
| SECONDARY Change in Epworth Sleepiness Scale (ESS) (4 Arm) |
-0.6; -1.0; -1.9; -1.6 | — |
| SECONDARY Change in Patient Health Questionnaire (PHQ8) (4 Arm) |
-0.4; -0.9; -1.7; -1.4 | — |
| SECONDARY Change in the Calgary Sleep Apnea Quality of Life Index (SAQLI) (4 Arm) |
0.1; 0.2; -0.1; -0.1 | — |
| SECONDARY Change in C-Reactive Protein at Months 6 and 12 (4 Arm) |
0.2; -0.02; 0.0003; 0.2; 0.2; 0.1 | — |
| SECONDARY Change in Lipid Panel at 6 and 12 Months (4 Arm) |
9.4; 1.5; 4.0; 1.8; -0.5; 1.7 | — |
| SECONDARY Change in Glucose, Fibrinogen, Creatinine and BNP at Months 6 and 12 (4 Arm) |
2.9; 3.9; 10.9; 1.0; 18.9; -2.0 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c Percentage at Months 6 and 12 (4 Arm) |
0.1; -0.2; -0.04; 0.1 | — |
| SECONDARY Change From Baseline in Fasting Insulin at Months 6 and 12 (4 Arm) |
-0.9; 2.8; -2.4; 1.1 | — |
| SECONDARY Change in Interleukin 6 (IL-6) at Months 6 and 12 (4 Arm) |
5.3; 0.5; -2.5; 0.4 | — |
| SECONDARY Change in Glomerular Filtration Rate (GFR) at Months 6 and 12 (4 Arm) |
-0.2; 0.6; 0.007; -1.15 | — |
| SECONDARY Change in Urine Microalbumin at Months 6 and 12 (4 Arm) |
-16.7; 45.4; 3.7; 8.2 | — |
| SECONDARY Change in Urinary Albumin Creatinine Ratio at Months 6 and 12 (4 Arm) |
-9.3; 84.6; 1.2; 6.0 | — |
| SECONDARY Change in Plasminogen Activator Inhibitor-1 (PAI-1) at Months 6 and 12 (4 Arm) |
0.8; 0.2; 1.1; 0.3 | — |
| SECONDARY Change in Pulse Wave Velocity (PWV) at Months 6 and 12 (4 Arms) |
0.05; -0.03; -0.2; 0.1 | — |
| SECONDARY Change in Augmentation Index at Months 6 and 12 (4 Arms) |
-1.2; -0.4; 0.9; -0.9 | — |
| SECONDARY Left Ventricular (LV) Mass Index (4 Arm) - Baseline |
82.4; 78.5; 77.0; 76.3 | — |
| SECONDARY Left Atrial (LA) Volume Index (4 Arm) - Baseline |
27.1; 25.3; 25.1; 24.2 | — |
| SECONDARY End-Diastolic Volume (4 Arm) - Baseline |
113.8; 111.8; 113.4; 112.3 | — |
| SECONDARY Ejection Fraction (4 Arm) - Baseline |
60.2; 60.9; 60.8; 59.9 | — |
| SECONDARY Right Ventricular Fractional Area Change (4 Arm) - Baseline |
0.5; 0.5; 0.5; 0.5 | — |
| SECONDARY Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - Baseline |
14.2; 13.1; 13.5; 13.1 | — |
| SECONDARY Pulmonary Vascular Resistance (4 Arm) - Baseline |
154.6; 135.5; 151.1; 157.0 | — |
| SECONDARY E/Em Lateral Ratio (4 Arm) - Baseline |
8.6; 8.3; 8.4; 7.9 | — |
| SECONDARY Peak Tricuspid Regurgitation Velocity (4 Arm) - Baseline |
243.5; 240.4; 244.0; 248.3 | — |
| SECONDARY Left Ventricular Mass Index (4 Arm) - 12 Month |
82.1; 76.9; 74.2; 70.4 | — |
| SECONDARY Left Atrial Volume Index (4 Arm) - 12 Month |
25.5; 22.3; 24.6; 20.7 | — |
| SECONDARY End-Diastolic Volume (4 Arm) - 12 Month |
110.7; 112.3; 115.5; 106.1 | — |
| SECONDARY Ejection Fraction (4 Arm) - 12 Month |
61.1; 61.4; 60.6; 60.9 | — |
| SECONDARY Right Ventricular Fractional Area Change (4 Arm) - 12 Month |
0.5; 0.5; 0.5; 0.5 | — |
| SECONDARY Tricuspid Annular Peak Systolic Myocardial Velocity (4 Arm) - 12 Month |
14.1; 13.5; 13.6; 14.1 | — |
| SECONDARY Pulmonary Vascular Resistance (4 Arm) - 12 Month |
148.4; 138.2; 144.0; 131.3 | — |
| SECONDARY E/Em Lateral Ratio (4 Arm) - 12 Month |
8.8; 8.2; 9.2; 8.4 | — |
| SECONDARY Peak Tricuspid Regurgitation Velocity (4 Arm) - 12 Month |
235.4; 253.1; 232.0; 254.7 | — |
Summary
Moderate to severe sleep apnea (a high number of breathing pauses on a sleep study) is a common health problem that is often associated with loud snoring and sleepiness.The medical term for this problem is obstructive sleep apnea (OSA). People with OSA often have an increased risk for developing heart disease or may already have a diagnosis of heart disease.
A clinical research study is being conducted at Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC) to compare the effects of continuous positive airway pressure (CPAP) to conservative medical therapy with participation in one of four groups:
1. Active-PAP Therapy Group (Active-Beh or Active+Beh): Will receive standard medical treatment for sleep apnea with active-PAP. Participants will be randomized to either:
1. Active-Pap with respiratory therapist visits only
2. Active-Pap with respiratory therapist visits and cognitive behavioral therapist visits.
2. Alternative PAP Group (Sham): Will receive lower air delivery level than active-PAP therapy group. Will also have meetings with respiratory therapist.
3. Conservative Medical Therapy Group (CMT)*: Will receive a free supply of nasal strips for the duration of their treatment period (either 6 months or 12 months) and follow healthy sleep hygiene guidelines for how to change sleep habits to minimize incidences of apneas (breathing disturbances during sleep). Frequent follow-up support with research coordinator.
A sleep doctor or cardiologist will have indicated that a potential participant is an appropriate candidate to receive PAP or CMT as acceptable approaches to treat his/her sleep apnea. Participants will be recruited between the ages of 45-75 years who have diagnosed heart disease or between 55-75 years for those who have risk factors for developing heart disease.
This is a 6-12 month study** to evaluate alternative ways to address the potential for OSA treatment to reduce heart disease and to identify those features that would strengthen a later, large-scale randomized controlled trial.
We will test the hypothesis that active treatment for OSA with CPAP reduces CVD morbidity and mortality.
*All randomized participants will be given conservative medical therapy (CMT).
**For those randomized after December 31, 2012, follow-up assessment will only be 6 months long
Eligibility Criteria
Inclusion Criteria
- Obstructive apnea hypopnea index (AHI) ≥ 15
- Age 45-75 years, or 55 to 75 yrs if without established Cardiovascular Disease (CVD)
- Ability to provide informed consent, with the patient and physician acknowledging accepting uncertainty on the role of PAP in CVD prevention.
- Established CVD, or having diabetes mellitus, defined by one or more of the following:
- Prior myocardial infarction
- Coronary artery revascularization procedure (≥4 months before study entry)
- Angiographically documented stenosis (>70%) of a major coronary artery
- Prior ischemic stroke without major functional impairment
- Diabetes mellitus treated with medication or ≥ 2 fasting glucose levels ≥ 126 mg/dl
OR
Three or more of the following established CVD risk factors:
- Hypertension treated with medications or systolic BP > 140 or diastolic BP > 90 on ≥ 2 occasions
- Male sex
- BMI ≥ 30
- Total cholesterol > 240 mg/dl or LDL cholesterol > 160 mg/dl or HDL 10 pack years of smoking
Exclusion Criteria
- Diagnosed heart failure with known cardiac ejection fraction of 170/>100)
- Prior stroke with functional impairment interfering with ability to complete the protocol
- Severe uncontrolled medical problems or medications that may influence measurements or impair ability to participate in the study exams (e.g. oral steroids; chronic opioid use; self- reported chronic kidney disease or, if measured, creatinine > 2.5 mg/dl or glomerular filtration rate (GFR) 10% of the sleep period;
- Use of prescribed PAP for sleep apnea within the prior 2 years
- Report of inability to spend >6 hrs in bed
- Any use of prescribed PAP for sleep apnea
- Severe sleepiness defined by an Epworth Sleepiness Score of >14 or report of falling asleep driving in the prior 2 years
- Working as a professional driver
- Low risk related to having sleep apnea defined by a Berlin Score 50% of respiratory events classified as central apneas
- Refusal to consider PAP use after an initial split-night PAP study (pre-randomization)
- Concurrent involvement in another research study that will result in a conflict as determined by study doctors
Data sourced from ClinicalTrials.gov (NCT01261390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.