Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

Sleep Apnea Clinical Trial

Official title:

Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927547
• Other study ID #: IRB00170895
• Secondary ID: R34HL135360
• Status: Completed
• Phase: N/A
• Start date: September 29, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Heart Disease
• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

Device:
• Inclined Sleep
Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.

Locations

Country	Name	City	State
Peru	Prisma Org	Puno

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Change in average plasma hemoglobin concentration (g/dL)		Baseline, 8 weeks
Secondary	Change in average Glycated hemoglobin test (HbA1c)	This will measure percentage (%) of HbA1c in the blood.	Baseline, 8 weeks
Secondary	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
Secondary	Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations	Plasma levels of SVEGF-1 (pg/mL)	Baseline, 8 weeks
Secondary	Change in homeostatic model assessment of insulin resistance (HOMA-IR)	Units of measurement is mass units.	Baseline, 8 weeks
Secondary	Change in total plasma cholesterol level (mg/dL)		Baseline, 8 weeks
Secondary	Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)		Baseline, 8 weeks
Secondary	Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)		Baseline, 8 weeks
Secondary	Change in plasma triglyceride concentration (mg/dL)		Baseline, 8 weeks
Secondary	Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration	Units of measurement pg/mL	Baseline, 8 weeks
Secondary	Change in mean blood pressure (mmHg)		Baseline, 8 weeks
Secondary	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