DeVilbiss AutoAdjust With SmartFlex Comparative Study

DeVilbiss Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Standard; Device: SmartFlex

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203956

DHC-C001

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

SmartFlex

Experimental group

Description:

Use Continuous Airway Pressure device with SmartFlex engaged

Treatment:

Device: SmartFlex

Standard

Active Comparator group

Description:

Use Continuous Airway Pressure device without SmartFlex engaged

Treatment:

Device: Standard