DeVilbiss AutoAdjust With SmartFlex Comparative Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DeVilbiss Healthcare LLC
ClinicalTrials.gov Identifier:
NCT01203956
First received: August 31, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Device: Positive Airway Pressure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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"

Resource links provided by NLM:


Further study details as provided by DeVilbiss Healthcare LLC:

Primary Outcome Measures:
  • The primary aim of the study will be to compare the effectiveness of the AutoAdjust with and without the SmartFlex technology in reducing AHI. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Key measures that will be used to evaluate the intervention(s) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 28
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auto Adjust/SmartFlex Device: Positive Airway Pressure
A crossover study with and without smartflex engaged, each period lasting for two weeks.
Other Name: DeVilbiss AutoAdjust with SmartFlex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epworth Sleepiness Scale >10
  • Body Mass Index > 26
  • AHI≥15 (mod to severe range)
  • AHI ≤ 10 at therapeutic CPAP pressure
  • CPAP naïve patients
  • PSG within 3 months of enrollment
  • Average SpO2 > 90% during titration
  • Sleep efficiency on titration night ≥ 78%

Exclusion Criteria:

  • Diagnosis of mild OSA
  • Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203956

Locations
United States, Texas
Sleep Medicine Associates of Texas
Dallas, Texas, United States, 75231
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
DeVilbiss Healthcare LLC
Investigators
Principal Investigator: Leon Rosenthal, MD Sleep Medicine Associates of Texas
  More Information

No publications provided

Responsible Party: DeVilbiss Healthcare LLC
ClinicalTrials.gov Identifier: NCT01203956     History of Changes
Other Study ID Numbers: DHC-C001
Study First Received: August 31, 2010
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by DeVilbiss Healthcare LLC:
AutoAdjust
SmartFlex
Apnea Hypopnea Index
Patient reported outcomes

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014