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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philips Respironics

Boston, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Paced Breathing

Device

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 names: Respironics

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing

Acronym: PBSW

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 15, 2009
Registry last updated: May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed