DeVilbiss AutoAdjust With SmartFlex Comparative Study

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.

Key facts

Study ID

NCT01203956

Run by

DeVilbiss Healthcare LLC

People needed

28

Starts

2010-09-01

Expected to finish

2011-05-01

Last updated by the study team

2015-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• Sleep Medicine Associates of Texas — Dallas, Texas, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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