NCT03927547

Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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),

Conditions

• Sleep Disordered Breathing
• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inclined Sleep	Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.

Timeline

• Start date: 2019-09-29
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2019-04-25
• Last updated: 2020-11-06

Locations

1 site across 1 country: Peru