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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL135360 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
Specific Aims:
Primary outcomes, at 4 and 8 weeks:
Secondary outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclined Sleep | Experimental | Inclined mattress at 15 degrees |
|
| Flat Sleep | No Intervention | Plane mattress |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclined Sleep | Device | Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Disturbance Index (RDI) | 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 | Baseline, 4 weeks, 8 weeks |
| Change in Mean oxyhemoglobin saturation (percent) during sleep | The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8. | Baseline, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of postural therapy as assessed by adherence monitor | 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. | 2, 4, 6 and 8 weeks |
| Change in average plasma hemoglobin concentration (g/dL) |
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Inclusion criteria
Exclusion criteria
The following exclusion criteria apply only for those undergoing spirometry for safety reasons. Participants with any one of these criteria, will be excluded from spirometry but can still participate in the rest of the screening phase:
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| Name | Affiliation | Role |
|---|---|---|
| William Checkley | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Org | Puno | Peru |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Subjects will undergo sleep study in subjects' randomized sleep posture. Randomization will be recorded separately from sleep study recordings. These recordings will be reviewed by trained sleep study technicians who will be blinded to randomization. Blood samples will also be assayed for markers of glucose control.
| Baseline, 8 weeks |
| Change in average Glycated hemoglobin test (HbA1c) | This will measure percentage (%) of HbA1c in the blood. | Baseline, 8 weeks |
| Change in serum erythropoietin (EPO) concentration | 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. | Baseline, 8 weeks |
| Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations | Plasma levels of SVEGF-1 (pg/mL) | Baseline, 8 weeks |
| Change in homeostatic model assessment of insulin resistance (HOMA-IR) | Units of measurement is mass units. | Baseline, 8 weeks |
| Change in total plasma cholesterol level (mg/dL) | Baseline, 8 weeks |
| Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL) | 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 |
| Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration | Units of measurement pg/mL | Baseline, 8 weeks |
| Change in mean blood pressure (mmHg) | Baseline, 8 weeks |
| Change in Brachial Artery Reactivity Testing (BART) assessment | 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. | Baseline, 8 weeks |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |