Positive Pressure Treatment of Obstructive Sleep Apnea
This study has been completed.
Sponsor:
Philips Respironics
Information provided by:
Philips Respironics
ClinicalTrials.gov Identifier:
NCT00636181
First received: February 6, 2008
Last updated: June 9, 2009
Last verified: June 2009
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Purpose
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Hypopnea Syndrome |
Device: Auto AFlex Device: Auto CPAP Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes |
Resource links provided by NLM:
Further study details as provided by Philips Respironics:
Primary Outcome Measures:
- Adequate reduction of apnea hypopnea index from baseline. [ Time Frame: 180 Days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average hours of nightly use. [ Time Frame: 180 days ] [ Designated as safety issue: No ]
- Psychomotor vigilance testing,Functional outcomes of sleep questionnaire, Epworth Sleepiness Scale, Attitudes Toward Use, and subjective assessment of therapy comfort. [ Time Frame: 180 Days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Auto Aflex
auto adjusting positive pressure therapy with AFLEX
|
Device: Auto AFlex
Positive pressure therapy treatment
|
|
Active Comparator: Auto CPAP
auto adjusting positive pressure therapy
|
Device: Auto CPAP
Positive pressure therapy treatment
|
|
Active Comparator: CPAP
continuous positive airway pressure
|
Device: CPAP
Positive pressure therapy treatment
|
Detailed Description:
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636181
Locations
| United States, Alabama | |
| Sleep Disorders Center of Alabama | |
| Birmingham, Alabama, United States, 35213 | |
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94304 | |
| United States, Connecticut | |
| Gaylord Hospital | |
| New Haven, Connecticut, United States, 06472 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32608 | |
| Germany | |
| Charite Universitatsmedizin Berlin | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Philips Respironics
Investigators
| Principal Investigator: | Clete A. Kushida, M.D.; Ph.D; | Stanford University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clete Anthony Kushida, M.D., Ph.D, RPSGT, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00636181 History of Changes |
| Other Study ID Numbers: | CTG3 |
| Study First Received: | February 6, 2008 |
| Last Updated: | June 9, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 13, 2013