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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT00725595
Eligibility Criteria:
Inclusion Criteria:
1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
2. Subject is \> 18 years old
3. Patients with known history of CSR. CSR symptoms may include the following:
* sleep fragmentation as reported by patient or as witnessed by another person
* night arousal after apneic episodes
* reduced exercise capacity
* daytime sleepiness
4. Expected to tolerate the ventilator therapy
Exclusion Criteria:
1. Baseline oxygen saturation \< 90% on a stable FIO2)
2. Patient is currently enrolled in another clinical study which may confound the results of this study
3. Patient for whom informed consent cannot be obtained
4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
6. Patients with severe COPD (per GOLD scale)
7. Patients with a history of myocardial infarction within the 6 months prior to the study
8. Patients with unstable angina
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00725595
Study Brief:
Protocol Section:
NCT00725595