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DeVilbiss AutoAdjust With SmartFlex Comparative Study

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SmartFlex
Standard
Sponsored by
DeVilbiss Healthcare LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sleep Medicine Associates of Texas
  • Sleep Therapy and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SmartFlex

Standard

Arm Description

Use Continuous Airway Pressure device with SmartFlex engaged

Use Continuous Airway Pressure device without SmartFlex engaged

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 31, 2010
Last Updated
April 8, 2015
Sponsor
DeVilbiss Healthcare LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01203956
Brief Title
DeVilbiss AutoAdjust With SmartFlex Comparative Study
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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DeVilbiss Healthcare LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SmartFlex
Arm Type
Experimental
Arm Description
Use Continuous Airway Pressure device with SmartFlex engaged
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Use Continuous Airway Pressure device without SmartFlex engaged
Intervention Type
Device
Intervention Name(s)
SmartFlex
Other Intervention Name(s)
DeVilbiss AutoAdjust with SmartFlex
Intervention Description
Device used with smartflex engaged.
Intervention Type
Device
Intervention Name(s)
Standard
Other Intervention Name(s)
DeVilbiss AutoAdjust without SmartFlex
Primary Outcome Measure Information:
Title
Apnea-hypopnea Index (AHI)
Description
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Key Measures That Will be Used to Evaluate the Intervention(s)
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Rosenthal, MD
Organizational Affiliation
Sleep Medicine Associates of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Medicine Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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DeVilbiss AutoAdjust With SmartFlex Comparative Study

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