MedTrace Logo

Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea

NCT02250417 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-08-08

Study results available
· View outcomes & findings →

Summary

Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA.

The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.

Conditions

  • Sleep Apnea, Obstructive

Interventions

OTHER

Wave sleep surface

The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.

Sponsors & Collaborators

  • Hill-Rom

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Ulysses J Magalang, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02250417 on ClinicalTrials.gov