DeVilbiss AutoAdjust With SmartFlex Comparative Study

Obstructive Sleep Apnea Clinical Trial

Official title:

A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; "AutoAdjust With SmartFlex Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203956
• Other study ID #: DHC-C001
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: April 8, 2015
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2015
• Source: DeVilbiss Healthcare LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• SmartFlex
Device used with smartflex engaged.
• Standard

Locations

Country	Name	City	State
United States	Sleep Medicine Associates of Texas	Dallas	Texas
United States	Sleep Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DeVilbiss Healthcare LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea Index (AHI)	Number of apnea/hypopnea events per hour, measured by SmartLink component of device.	4 weeks	No
Secondary	Key Measures That Will be Used to Evaluate the Intervention(s)	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	2 weeks	No