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Hill-Rom WAVE for Positional Obstructive Sleep Apnea at Home

NCT03971721 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-03-16

Study results available
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Summary

1. Determine the effects of a mattress support (Wave 4.3) that promotes the avoidance of supine airway position at home on the apnea-hypopnea index (AHI) in patients with positional obstructive sleep apnea (OSA).
2. Determine the effects of Wave 4.3 on subjective measures of sleepiness and daytime function in patients with positional OSA.
3. Determine the effects of Wave 4.3 on subjective measures of sleep quality in patients with positional OSA.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Wave 4.3

The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.

Sponsors & Collaborators

  • Hill-Rom

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Ulysses Magalang, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-01-01
Completion
2020-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971721 on ClinicalTrials.gov