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Sponsored by: |
Respironics |
---|---|
Information provided by: | Respironics |
ClinicalTrials.gov Identifier: | NCT00636181 |
Three 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: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
Official Title: | Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes |
Estimated Enrollment: | 150 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Auto Aflex: Active Comparator
auto adjusting positive pressure therapy with AFLEX
|
Device: Auto AFlex
Positive pressure therapy treatment
|
Auto CPAP: Active Comparator
auto adjusting positive pressure therapy
|
Device: Auto CPAP
Positive pressure therapy treatment
|
CPAP: Active Comparator
continuous positive airway pressure
|
Device: CPAP
Positive pressure therapy treatment
|
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Presence of untreated or poorly managed, non-OSAHS related sleep disorders:
Contact: Clete A. Kushida, M.D., Ph.D; | 650-725-1915 | clete@stanford.edu |
United States, Alabama | |
Sleep Disorders Center of Alabama | Recruiting |
Birmingham, Alabama, United States, 35213 | |
Contact: G. Vernon Pegram, M.D. 205-599-1020 vpegram@sleepalabama.com | |
Sub-Investigator: G. Vernon Pegram, Ph.D | |
United States, California | |
Stanford University | Recruiting |
Stanford, California, United States, 94304 | |
Contact: Clete A. Kushida, M.D. Ph.D 650-725-1915 clete@stanford.edu | |
Principal Investigator: Clete A. Kushida, M.D. Ph.D | |
United States, Connecticut | |
Gaylord Hospital | Recruiting |
New Haven, Connecticut, United States, 06472 | |
Sub-Investigator: Meir H. Kryger, M.D., FRCPC | |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32608 | |
Sub-Investigator: Richard Berry, M.D. | |
Germany | |
Charite Universitatsmedizin Berlin | Recruiting |
Berlin, Germany, 10117 | |
Sub-Investigator: Ingo Fietze, M.D. Ph.D |
Principal Investigator: | Clete A. Kushida, M.D.; Ph.D; | Stanford University |
Responsible Party: | Stanford University ( Clete Anthony Kushida, M.D., Ph.D, RPSGT ) |
Study ID Numbers: | CTG3 |
Study First Received: | February 6, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00636181 History of Changes |
Health Authority: | United States: Institutional Review Board |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Sleep Apnea Syndromes Disease Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias |
Sleep Disorders Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory |