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:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01203956
Eligibility Criteria:
Inclusion Criteria:
* Epworth Sleepiness Scale \>10
* Body Mass Index \> 26
* Apnea-hypopnea index (AHI) ≥15 (mod to severe range)
* AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure
* CPAP naïve patients
* Polysomnogram (PSG) within 3 months of enrollment
* Average oxygen saturation by pulse oximetry (SpO2) \> 90% during titration
* Sleep efficiency on titration night ≥ 78%
Exclusion Criteria:
* Diagnosis of mild obstructive sleep apnea (OSA)
* Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01203956
Study Brief:
Protocol Section:
NCT01203956