Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

Johns Hopkins University

Status

Completed

Conditions

Sleep Disordered Breathing

Sleep Apnea

Treatments

Device: Inclined Sleep

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03927547

IRB00170895

R34HL135360 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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),

Enrollment

54 patients

Sex

All

Ages

40 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Age 40-80 years
Daytime oxyhemoglobin saturation ≥80%, seated.
Body mass index ≥25 kg/m2
Hemoglobin >13 g/dL in women and >15 g/dL in men
Ability to provide informed consent
Sleeps at home in same bed every night
Expected stable residence for at least 6 months
Sleeps with two pillows or fewer
Demonstrate acute improvement in SDB severity with postural therapy
Able to sleep ≥5 hours at an incline for all three nights during the run-in period

Exclusion criteria

Works the night-shift or a rotating shift
Has an indication or preference for sleeping upright, semi-recumbent or at an incline
Chronic insomnia or a non-respiratory sleep disorder
Physician-established diagnosis of diabetes, lung, cardiovascular, liver, or chronic kidney disease
Using home oxygen therapy or other respiratory assistive device [e.g., continuous positive airway pressure (CPAP), nebulizer]
Self-reported severe gastrointestinal reflux
Self-report of occult blood or history of gastrointestinal bleeding in the past 3 months
Pregnancy
Unable to sleep ≥5 hours at an incline for all three nights during the run-in period

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:

Surgery of the heart, chest, lungs in the past 3 months (participants will be revisited at a later period)
Heart attack in the past 3 months (participants will be revisited at a later period)
History of eye surgery
History of abdominal surgery in the past 3 months.