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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT00177892
Eligibility Criteria:
Inclusion Criteria:
* Nonsmoker for at least 6 months
* No history of movement disorder during sleep, or circadian rhythm disorder
* No excessive daytime sleepiness
* No history of chronic insomnia, mood or affective disorders or other psychiatric disorders
* Participants maintain a regular sleep-wake pattern with an estimated sleep time between 6.5 and 10 hours per night
* Ability and willingness to avoid meat with its juice (gravy), cured or smoked foods and green leafy vegetables, fruit and fruit juices, food products or vitamin supplements containing vitamin C and E supplements for at least 1 day prior to and during the study periods
* Consumption of less than 1 alcoholic beverage per day
* Ability to understand the study and sign the informed consent
* Not currently pregnant
* Live within 45 miles of the study site
* No uncontrolled hypertension (blood pressure greater than 150/100)
* Willingness to avoid caffeinated beverages and food during the study protocol period
Participants With Sleep Apnea:
* Diagnosis of severe Obstructive Sleep Apnea and Hypopnea (OSAH) (RDI greater than 25) and initiation of positive airway pressure therapy more than 1 month before enrollment
* Must have had an adequate clinical titration of positive airway pressure therapy
* On positive airway pressure for at least 1 month with adherence of more than 5 hours of use per day with no history of snoring, no excessive daytime sleepiness and no reported observed apnea episodes on positive airway pressure
* Willing to sleep with and without positive airway pressure therapy as required by the study protocol
Exclusion Criteria:
* History or physical examination evidence of active coronary artery disease, heart failure, cardiomyopathy, syncope, potentially life-threatening arrhythmia, stroke, transient ischemic attack, neurologic impairment, renal, hepatic or thyroid disease (unless on stable thyroid replacement medication); history of diabetes mellitus; history of cancer within the past 10 years (other than basal cell carcinoma), venous thrombosis, or collagen-vascular disease or other condition that the investigators believe may be exacerbated by participation in the stud
* History of awakening with angina pectoris
* Currently taking medication for mood or affective disorders or that affect heme metabolism, autonomic nervous system or sleep architecture, or prescribed nitrates or corticosteroids
* Physician-diagnosed Alzheimer's or non-Alzheimer's dementia
* Previous surgery for sleep apnea
* Hematocrit less than 32
* Use of a hearing aid in one or both ears
* History of a bleeding disorder, abnormal bleeding, or known adverse reaction to heparin
* Inability to obtain venous blood or a low likelihood of obtaining venous access as required in this protocol
* History of migraine of a nature, frequency, and severity that, in the investigators' judgement, may be precipitated by participation in the protocol
* Presence of a potentially life-threatening dysrhythmia on the clinical diagnostic PSG
* History of motor vehicle accident due to falling asleep; not currently employed as a driver in the transportation industry or an airplane pilot
* Lipid-lowering agents for participants without a history of sleep apnea
* Individuals on positive airway pressure therapy for sleep apnea must not have lost more than 10 pounds of weight since starting this treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00177892
Study Brief:
Protocol Section:
NCT00177892