DeVilbiss AutoAdjust With SmartFlex Comparative Study

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Standard; Device: SmartFlex

• Registration Number: NCT01203956
• Lead Sponsor: DeVilbiss Healthcare LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-31
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2015-03-24
• Status Verified: 2015-04
• Results First Submitted QC: 2015-04-08
• Last Update Submitted: 2015-04-08
• Results First Posted: 2015-04-28
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard	Standard	Use Continuous Airway Pressure device without SmartFlex engaged
SmartFlex	SmartFlex	Use Continuous Airway Pressure device with SmartFlex engaged

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea Index (AHI)	4 weeks	Number of apnea/hypopnea events per hour, measured by SmartLink component of device.

Secondary Outcome Measures

Name	Time	Method
Key Measures That Will be Used to Evaluate the Intervention(s)	2 weeks	The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device

Trial Locations

Locations (2)

Sleep Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

Sleep Medicine Associates of Texas; 🇺🇸 Dallas, Texas, United States