N/A
N=36
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01031914 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Sleep/Wake Algorithm — 62 accuracy (%)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Paced Breathing (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep/Wake Algorithm |
62 | — |
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.
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 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).
Data sourced from ClinicalTrials.gov (NCT01031914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.