Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2010-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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SmartFlex
Use Continuous Airway Pressure device with SmartFlex engaged
SmartFlex
Device used with smartflex engaged.
Standard
Use Continuous Airway Pressure device without SmartFlex engaged
Standard
Interventions
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SmartFlex
Device used with smartflex engaged.
Standard
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index \> 26
* Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
* AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
* CPAP naïve patients
* Polysomnogram (PSG) within 3 months of enrollment
* Average oxygen saturation by pulse oximetry (SpO2) \> 90% during titration
* Sleep efficiency on titration night ≥ 78%
Exclusion Criteria
* Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness
* Allergies to mask materials
* Difficulties with nasal breathing
* Evidence of another primary sleep disorder
* Evidence of arousing periodic limb movements during titration
* Contraindications as listed on product labeling.
* Pregnant
* Currently diagnosed with depression if symptomatic
* Predominately central sleep apnea
* Deemed medically unsuitable by investigator
* Evidence of any type of infection or treatment of an infectious condition during the period of research participation
* Full Face Mask during titration
* Have a bi-level requirement
* CPAP pressure \>15cmH2O
* Subjects with tracheotomy
* Uncontrolled hypertension
* Require supplemental oxygen
* Stimulants, major tranquillizers or antipsychotics.
18 Years
ALL
No
Sponsors
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DeVilbiss Healthcare LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Leon Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Sleep Medicine Associates of Texas
Locations
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Sleep Medicine Associates of Texas
Dallas, Texas, United States
Sleep Therapy and Research Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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DHC-C001
Identifier Type: -
Identifier Source: org_study_id
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