Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)

Obstructive Sleep Apnea Clinical Trial

Official title:

Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797705
• Other study ID #: DHC-002
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: May 7, 2015
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: DeVilbiss Healthcare LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Apnea hypopnea index = 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram

• Sleep efficiency reported on CPAP titration night PSG should be > 78%

• Diagnosis of moderate to severe obstructive sleep apnea (AHI =15) or central/complex sleep apnea

• On stable CPAP or APAP [Automatic Positive Airway Pressure] therapy, with compliant use averaging 4 or more hours nightly

• Age 21-75 years

• Predominately central sleep apnea for up to 10 subjects only

• Willingness to give written informed consent and ability to adhere to visit schedule

Exclusion Criteria:

Diagnosis of mild sleep apnea

• CPAP naïve patients

• Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD [Chronic Obstructive Pulmonary Disease] or psychiatric illness

• Allergies to mask materials

• 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

• Deemed medically unsuitable by investigator

• Evidence of any type of infection or treatment of an infectious condition during the period of research participation

• Have a bi-level requirement, or prescribed a bi-level therapy device

• CPAP pressure >15cmH2O

• Subjects with tracheotomy

• Uncontrolled hypertension

• Require supplemental oxygen

• Stimulants, major tranquillizers or antipsychotics

• Restless Leg Syndrome or Periodic Leg Movement Index of > 5 per hour

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• DeVilbiss AutoAdjust CPAP with revised algorithm
Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.

Locations

Country	Name	City	State
United States	NeuroCare, Inc.	Newton	Massachusetts

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	% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study	The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.	1 night	No