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Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)

NCT01031914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-05-14

Study results available
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Summary

The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be evaluating the algorithm's ability to correctly distinguish between sleep and wake.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Paced Breathing

The Paced Breathing (PB) feature(when activated) will work to relax the user and help them fall asleep by encouraging them to take deep slow breaths until they reach 10 breaths (or less) per minute. The feature will also detect when the subject has fallen asleep so the Continuous Positive Airway Pressur (CPAP) device will automatically switch from PB mode to regular CPAP mode.

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • David P White, M.D · Philips Respironics

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT01031914 on ClinicalTrials.gov