Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01797705
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01797705
Study Brief:
Protocol Section:
NCT01797705