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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01031914
First received: December 11, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Sleep Apnea, Obstructive
 Device: Paced Breathing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing

Resource links provided by NLM:

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

Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 36
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031914

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

No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01031914     History of Changes
Other Study ID Numbers: AR-0931-PBSW-SS
Study First Received: December 11, 2009
Results First Received: December 3, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013