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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02919904
Eligibility Criteria:
Inclusion Criteria:
1. Newly diagnosed prostate cancer starting hormone therapy with or without concomitant radiation therapy for at least 6 months, or
2. Biochemical relapse of prostate cancer without metastatic symptoms (i.e. rising Prostate-specific antigen (PSA) after definitive therapy with no evidence of metastatic disease)\*.
3. Serum testosterone in the hypogonadal range or above, but not at castrate levels.
4. About to start ADT with a Luteinizing Hormone-Releasing Hormone (LHRH) analogue for at least 6 months.
5. Fluent in English (able to read, write, and speak in English).
6. Provide written informed consent.
7. Patients with sleep apnea who do not depend on a CPAP (continuous positive airway pressure) machine to sleep may join the study.
* Note: For participants who are having both hormone therapy and radiation, sleep parameters will only be measured before the participant starts radiation.
Exclusion Criteria:
1. Receiving antiandrogen monotherapy.
2. Previous history of sleep disorder (e.g., being treated for obstructive sleep apnea (and wear a CPAP machine), narcolepsy, parasomnia, circadian rhythm abnormalities).
3. Use of routine prescription or over the counter sleep medications (e.g., melatonin, zolpidem, suvorexant, eszopiclone, ramelteon, benzodiazepine, antihistamine).
4. Active medical problems that interfere with sleep (e.g. congestive heart failure).
5. Active medical problems that interfere with ARESTM reading or use of the device: deafness, blindness, severe arthritis, dementia, atrial fibrillation, tics or tremors of the head.
6. Use of supplemental oxygen at night.
7. Sensitivity of skin or scalp and/or open wounds on the forehead or scalp.
8. Allergic reactions to extended exposure to synthetics fabrics (e.g. polyester, rayon).
9. Upper respiratory infection or congestion.
10. Inability to sleep at least 5 hours per night or a total of 8 hours over two nights.
11. Inability to sleep with head reclined (less than 60 degree angle).
12. Head circumference less than 21 inches or greater than 25 inches.
13. Any reason that would prevent the participant from completing the study protocol or medical reason that would preclude them taking part.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02919904
Study Brief:
Protocol Section:
NCT02919904