Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
- Conditions
- Sleep Disordered BreathingSleep Apnea
- Interventions
- Device: Inclined Sleep
- Registration Number
- NCT03927547
- Lead Sponsor
- Johns Hopkins University
- 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),
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inclined Sleep Inclined Sleep Inclined mattress at 15 degrees
- Primary Outcome Measures
Name Time Method Change in Mean oxyhemoglobin saturation (percent) during sleep 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) 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 Outcome Measures
Name Time Method Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations Baseline, 8 weeks Plasma levels of SVEGF-1 (pg/mL)
Change in average plasma hemoglobin concentration (g/dL) Baseline, 8 weeks Change in average Glycated hemoglobin test (HbA1c) Baseline, 8 weeks This will measure percentage (%) of HbA1c in the blood.
Change in serum erythropoietin (EPO) concentration Baseline, 8 weeks The concentration of EPO in the sample is expressed in International Units per litre (U/L) and is determined by calibration against a reference standard.
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 Adherence monitor will measure sleep over the set time points and tolerability is defined as a recorded time on the wedge for a minimum of 5 hours.
Change in homeostatic model assessment of insulin resistance (HOMA-IR) Baseline, 8 weeks Units of measurement is mass units.
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 Units of measurement pg/mL
Change in mean blood pressure (mmHg) Baseline, 8 weeks Change in Brachial Artery Reactivity Testing (BART) assessment Baseline, 8 weeks Assessed by endothelial function using high-frequency ultrasound visualized brachial artery reactivity testing. Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest to the diameter after increased forearm blood flow (reactive hyperemia).
Unit of measurement is mass units.Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL) Baseline, 8 weeks Change in plasma triglyceride concentration (mg/dL) Baseline, 8 weeks
Trial Locations
- Locations (1)
Prisma Org
🇵🇪Puno, Peru