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

NCT ID: NCT01031914

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Paced Breathing Sleep/Wake detection

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

Group Type: EXPERIMENTAL

Paced Breathing

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Respironics

Eligibility 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P White, M.D

Role: PRINCIPAL_INVESTIGATOR

Philips Respironics

Locations

Philips Respironics

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

AR-0931-PBSW-SS

Identifier Type: -

Identifier Source: org_study_id