Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disordered Breathing
- Sponsor
- Johns Hopkins University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Change in Mean oxyhemoglobin saturation (percent) during sleep
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB).
Detailed Description
Specific Aims: * To examine the relative efficacy of postural therapy (a 15-degree wedge mattress) on measures of chronic cardiometabolic stress in high altitude residents. * To determine the tolerability of postural therapy. Primary outcomes, at 4 and 8 weeks: * Mean nocturnal oxyhemoglobin saturation (SPO2) * Apnea-hypopnea index (AHI). Secondary outcomes * Markers of hypoxemia exposure: the investigators will evaluate for differences in average hemoglobin and erythropoietin concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data. * Markers of metabolic dysfunction: the investigators will evaluate for differences in average Glycated hemoglobin test (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), total cholesterol, low-density lipoprotein cholesterol (LDL), High-density lipoprotein cholesterol (HDL), triglycerides, SVEGF-R1 , and soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data. * Markers of cardiometabolic stress: the investigators will evaluate for differences in average systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse, and % change in endothelial function (reactive hyperemia index) as assessed by brachial artery reactivity testing (BART) between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate. * Adherence (the average number of nights during the 8-week period that participants slept on the wedge mattress),
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Mean oxyhemoglobin saturation (percent) during sleep
Time Frame: Baseline, 4 weeks, 8 weeks
The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.
Change in Respiratory Disturbance Index (RDI)
Time Frame: Baseline, 4 weeks, 8 weeks
The investigators will measure a change in Respiratory Disturbance Index (RDI) defined as an oxygen desaturation of at least 4 percent associated with autonomic signs of arousal. Specifically, autonomic arousals are defined as concurrent rises in heart rate and attenuation of arterial tonometry. Normal \< 5 percent 5 percent \< Mild \< 15 percent 15 percent \< Moderate \< 30 percent Severe \> 30 percent
Secondary Outcomes
- Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations(Baseline, 8 weeks)
- Change in average plasma hemoglobin concentration (g/dL)(Baseline, 8 weeks)
- Change in average Glycated hemoglobin test (HbA1c)(Baseline, 8 weeks)
- Change in serum erythropoietin (EPO) concentration(Baseline, 8 weeks)
- Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)(Baseline, 8 weeks)
- Tolerability of postural therapy as assessed by adherence monitor(2, 4, 6 and 8 weeks)
- Change in homeostatic model assessment of insulin resistance (HOMA-IR)(Baseline, 8 weeks)
- Change in total plasma cholesterol level (mg/dL)(Baseline, 8 weeks)
- Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration(Baseline, 8 weeks)
- Change in mean blood pressure (mmHg)(Baseline, 8 weeks)
- Change in Brachial Artery Reactivity Testing (BART) assessment(Baseline, 8 weeks)
- Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)(Baseline, 8 weeks)
- Change in plasma triglyceride concentration (mg/dL)(Baseline, 8 weeks)