Status:
COMPLETED
DeVilbiss AutoAdjust With SmartFlex Comparative Study
Lead Sponsor:
DeVilbiss Healthcare LLC
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
Eligibility Criteria
Inclusion
- Epworth Sleepiness Scale \>10
- 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
- Diagnosis of mild obstructive sleep apnea (OSA)
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01203956
Start Date
September 1 2010
End Date
May 1 2011
Last Update
April 28 2015
Active Locations (2)
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1
Sleep Medicine Associates of Texas
Dallas, Texas, United States, 75231
2
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229