Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders

NCT03927547 | Completed DMC

• 2 other identifiers: IRB00170895R34HL135360
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Disordered Breathing; Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Tolerability of postural therapy as assessed by adherence monitor

  2, 4, 6 and 8 weeks

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

  Baseline, 8 weeks

• Change in average Glycated hemoglobin test (HbA1c)

  Baseline, 8 weeks

• Change in serum erythropoietin (EPO) concentration

  Baseline, 8 weeks

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

  Baseline, 8 weeks

Study Arms (2)

Inclined Sleep

EXPERIMENTAL

Inclined mattress at 15 degrees

Device: Inclined Sleep

Flat Sleep

NO INTERVENTION

Plane mattress

Interventions

Inclined Sleep DEVICE

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

Also known as: wedge mattress, postural therapy

Inclined Sleep

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Prisma Org

Puno, Peru

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• William Checkley

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects will undergo sleep study in subjects' randomized sleep posture. Randomization will be recorded separately from sleep study recordings. These recordings will be reviewed by trained sleep study technicians who will be blinded to randomization. Blood samples will also be assayed for markers of glucose control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: September 29, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-03

Locations

PE (1)