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Completed

NCT Number: NCT03927547

Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

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).

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Org

Puno, Peru

About this study

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),

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inclined Sleep

Device

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

Other names: wedge mattress, postural therapy

Primary outcomes

  1. Change in Respiratory Disturbance Index (RDI)

    Time frame: Baseline, 4 weeks, 8 weeks

    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

  2. Change in Mean oxyhemoglobin saturation (percent) during sleep

    Time frame: Baseline, 4 weeks, 8 weeks

    The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.

Secondary outcomes

  1. Tolerability of postural therapy as assessed by adherence monitor

    Time frame: 2, 4, 6 and 8 weeks

    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. Change in average plasma hemoglobin concentration (g/dL)

    Time frame: Baseline, 8 weeks

  3. Change in average Glycated hemoglobin test (HbA1c)

    Time frame: Baseline, 8 weeks

    This will measure percentage (%) of HbA1c in the blood.

  4. Change in serum erythropoietin (EPO) concentration

    Time frame: Baseline, 8 weeks

    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.

  5. Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations

    Time frame: Baseline, 8 weeks

    Plasma levels of SVEGF-1 (pg/mL)

  6. Change in homeostatic model assessment of insulin resistance (HOMA-IR)

    Time frame: Baseline, 8 weeks

    Units of measurement is mass units.

  7. Change in total plasma cholesterol level (mg/dL)

    Time frame: Baseline, 8 weeks

  8. Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)

    Time frame: Baseline, 8 weeks

  9. Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)

    Time frame: Baseline, 8 weeks

  10. Change in plasma triglyceride concentration (mg/dL)

    Time frame: Baseline, 8 weeks

  11. Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration

    Time frame: Baseline, 8 weeks

    Units of measurement pg/mL

  12. Change in mean blood pressure (mmHg)

    Time frame: Baseline, 8 weeks

  13. Change in Brachial Artery Reactivity Testing (BART) assessment

    Time frame: Baseline, 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2019
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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