Status:
COMPLETED
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
Lead Sponsor:
DeVilbiss Healthcare LLC
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01797705
Start Date
January 1 2013
End Date
May 1 2014
Last Update
May 29 2015
Active Locations (1)
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1
NeuroCare, Inc.
Newton, Massachusetts, United States, 02459