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

NCT01031914 | Completed Results

• 1 other identifier: AR-0931-PBSW-SS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Paced Breathing; OSA; sleep/wake detection

Outcome Measures

Primary Outcomes (1)

• Sleep/Wake Algorithm

  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.

  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.

Study Arms (1)

Paced Breathing Sleep/Wake detection

EXPERIMENTAL

All subjects enrolled will have oobstructive sleep apnea (OSA) and will be current Continuous Positive Airway Pressur (CPAP) users.

Device: Paced Breathing

Interventions

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.

Also known as: Respironics

Paced Breathing Sleep/Wake detection

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Philips Respironics

Boston, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. David P. White
• Organization: Philips

Dr.DavidWhite@philips.com

724 387 4554

Study Officials

• David P White, M.D

  Philips Respironics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 15, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 14, 2013
• Results First Posted: May 14, 2013

Record last verified: 2013-04

Locations

US (1)