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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01031914
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Philips Respironics

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Paced Breathing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paced Breathing Sleep/Wake detection
All subjects enrolled will have oobstructive sleep apnea (OSA) and will be current Continuous Positive Airway Pressur (CPAP) users.
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.
Other Name: Respironics

Primary Outcome Measures :
  1. Sleep/Wake Algorithm [ Time Frame: The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours. ]
    We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 21-70
  • Diagnosis of obstructive sleep apnea (OSA)
  • Current adherent CPAP user (has been using CPAP nightly for at least 2 weeks).
  • On CPAP pressures of 5-10cm.
  • Subjects wishing to complete a day or evening appointment need to have significant daytime sleepiness (Epworth Sleepiness Scale score of 8 or above)
  • Able and willing to provide written informed consent
  • English speaking

Exclusion Criteria:

  • Participation in another interventional research study within the last 30 days
  • Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
  • Inability to tolerate nasal CPAP mask due to problems breathing solely through their nose.
  • Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCo2≥55mmHg)
  • Severe oxygen desaturation on the polysomnography (PSG), i.e. Sa02 < 70% for 10% of the study.
  • Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
  • Currently using supplemental oxygen
  • Regular use of sleeping pills or stimulants (> 3 nights a week)
  • Currently working night shift or rotating day/night shift
  • Drowsy Driving or near miss accident in the past 6 months
  • Inability to tolerate or track to Paced Breathing device during initial habituation session in lab
  • Chronic insomnia, Restless legs syndrome, or severe periodic limb movement disorder (PLMD - PLMAI>20/hr).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01031914

United States, Massachusetts
Philips Respironics
Boston, Massachusetts, United States, 02135
Sponsors and Collaborators
Philips Respironics
Principal Investigator: David P White, M.D Philips Respironics

Responsible Party: Philips Respironics Identifier: NCT01031914     History of Changes
Other Study ID Numbers: AR-0931-PBSW-SS
First Posted: December 15, 2009    Key Record Dates
Results First Posted: May 14, 2013
Last Update Posted: May 14, 2013
Last Verified: April 2013

Keywords provided by Philips Respironics:
Paced Breathing
sleep/wake detection

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases