N/A
Completed N=33
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
Source: ClinicalTrials.gov NCT01797705 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study — 92.2 percentage of agreement
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Agreement Between Reviewer and Machine Pressure Settings During Sleep Study |
92.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01797705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.