Trial Search Results
Positive Pressure Treatment of Obstructive Sleep Apnea
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Philips Respironics
Stanford Investigator(s):
Intervention(s):
- Device: Auto AFlex
- Device: Auto CPAP
- Device: CPAP
Phase:
N/A
Eligibility
Inclusion Criteria:
- Age 21 - 75
- Diagnosis of OSAHS with baseline AHI equal or greater than 15 events/hr of sleep
- Able and willing to provide written informed consent
- Agreement to try PAP as initial treatment approach
- Adequate clinical CPAP titration within two weeks of enrollment
Exclusion Criteria:
- Participation in another interventional research study within the last 30 days
- The need for more than one titration PSG
- The use of sedatives or hypnotics during the titration PSG
- Major medical or psychiatric condition that would interfere with the demands of the
study, adherence to PAP, or the ability to commit to follow-up assessment.
- Prior prescription for, or exposure to PAP therapy within the previous year (except
exposure to CPAP during clinical therapy titration.)
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular
disease, moderate or severe COPD or other pulmonary disorders, or any condition with
an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants
qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than
five minutes).
- Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty
(UPPP)
- Presence of untreated or poorly managed, non-OSAHS related sleep disorders:
- moderate to severe periodic limb movements (greater or equal to 15 per hour with
symptoms or arousals)
- Restless Leg syndrome (greater than 10 per hour)
- Males experiencing chronic insomnia
- Use of medications with hypnotic or sedative effects or regular use of night time
sedatives or sleeping aids greater than or equal to one night per week.
- Consumption of ethanol more than 4 nights per week (CAGE criteria)
- Shift workers
Ages Eligible for Study
21 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting