Study Results
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View full resultsBasic Information
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COMPLETED
NA
168 participants
INTERVENTIONAL
2008-01-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Auto Aflex
auto adjusting positive pressure therapy with AFLEX
Auto AFlex
Positive pressure therapy treatment
Auto CPAP
auto adjusting positive pressure therapy
Auto CPAP
Positive pressure therapy treatment
CPAP
continuous positive airway pressure
CPAP
Positive pressure therapy treatment
Interventions
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Auto AFlex
Positive pressure therapy treatment
Auto CPAP
Positive pressure therapy treatment
CPAP
Positive pressure therapy treatment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
* Able and willing to provide written informed consent
* Agreement to try PAP (positive airway pressure) as initial treatment approach
* Adequate clinical CPAP titration within two weeks of enrollment
Exclusion Criteria
* The need for more than one titration PSG (polysomnography)
* 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 (chronic obstructive pulmonary disease) 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
21 Years
75 Years
ALL
Yes
Sponsors
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Philips Respironics
INDUSTRY
Responsible Party
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Clete Kushida
Professor
Principal Investigators
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Clete A. Kushida, M.D.; Ph.D;
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Sleep Disorders Center of Alabama
Birmingham, Alabama, United States
Stanford University
Stanford, California, United States
Gaylord Hospital
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Charite Universitatsmedizin Berlin
Berlin, , Germany
Countries
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References
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Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085.
Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166.
Other Identifiers
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CTG3
Identifier Type: -
Identifier Source: org_study_id
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