Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

NCT ID: NCT03927547

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-29
• Study Completion Date: 2020-03-15

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),

Conditions

Sleep Disordered Breathing; Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inclined Sleep

Inclined mattress at 15 degrees

Group Type: EXPERIMENTAL

Inclined Sleep

Intervention Type: DEVICE

Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.

Flat Sleep

Plane mattress

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inclined Sleep

Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.

Intervention Type: DEVICE

Other Intervention Names

wedge mattress; postural therapy

Eligibility 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

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Checkley

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Prisma Org

Puno, , Peru

Countries

Peru

Other Identifiers

R34HL135360

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00170895

Identifier Type: -

Identifier Source: org_study_id