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

Philips

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Paced Breathing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01031914

AR-0931-PBSW-SS

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

36 participants in 1 patient group

Paced Breathing Sleep/Wake detection

Experimental group

Description:

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

Treatment:

Device: Paced Breathing