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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT04349059
Eligibility Criteria:
Inclusion Criteria:
* Subject provides written informed consent and HIPAA authorization in English before any study procedures are conducted.
* Subject is taking no medical therapy other than: prn MDIs, medication(s) for anxiety, depression, and/or ADHD (these medications include, but are not limited to, SSRIs, SNRIs, Stimulants), no change in supplements if applicable.
The anxiety, depression, and/or ADHD will have been controlled (per report of subject) for the last 6 months.
* IIEF score greater or equal to 22
* Subject will have had penile-sexual intercourse (either vaginal or anal penetration) within 12 weeks of enrollment.
* Male aged 18-35 years old
* Lives within commuting distance of Montefiore Health System
* Subject's significant other (if applicable) agrees to support the subject during the study
* Subject agrees to photograph and share all items consumed/drunk during the dietary intervention
* Subject agrees to avoid all illicit drugs, NSAIDS, and alcohol for at least two days prior to Rigiscan™ recording and on the days and nights of Rigiscan™ recording
* Subject agrees to refrain from sexual activity for at least 24 hours prior to Rigiscan™ placement and to have no sexual activity on the days and nights of Rigiscan™ recording.
* Subject agrees to not view, read, or otherwise consume erotic or pornographic material for 24 hours prior to both the days and nights of Rigiscan™ recording and on the days and nights of Rigiscan™ recording.
* Subject agrees to not have an orgasm for 24 hours prior to both the days and nights of RigiscanTM recording and on the days and nights of Rigiscan™ recording.
* Subject agrees to come to Montefiore to undergo Rigiscan™ training
* Subject agrees to only consume/drink permitted food/beverages.
* Subject agrees to attend all in person visits at Montefiore, to begin fasting at 11pm the night before each visit, and to undergo all blood draws/salivary/other testing.
* Subject agrees to not use mouthwash or mouth rinses or intentionally spit for the entire duration of the study. Subjects will be asked to refrain from using mouthwash for at least 2 days prior to enrollment. Subject agrees to not brush his teeth in the morning of the day of each study visit. Tooth brushing is otherwise permissible.
* BMI \<30, BMI \>=18.5, weight \>110 lbs.
* Subject agrees to comply with the study procedures and visits.
* Subject exercises for at least 15 minutes at least two times per week
* If exercise is done, subjects will exercise for the same amount of time and at a similar intensity each day of Rigiscan™ testing. Otherwise, no exercise will be performed on Rigiscan™ days.
* If enrolled, subjects agree to not modify their dietary habits throughout the duration of the study other than during the two evenings and two full days when food is provided.
Exclusion Criteria:
* Relevant dietary allergy
* Vegetarian or Vegan dietary pattern
* History of an eating disorder and/or food addiction
* Hypertension and or history of hypertension with or without medical treatment. Systolic blood pressure \> 150mmHg and/or diastolic blood pressure \>100mmHg on Visit one. Heart rate \>99 on Visit one. Systolic blood pressure \< 85mmHg and/or diastolic blood pressure \< 50mmHg on Visit one. Heart rate \< 35 on Visit one.
* BMI \>=30, BMI \<18.5, or weight \<= 110lbs
* Known chronic medical disease other than non-inflammatory musculoskeletal disease, asthma, anxiety, depression, and/or ADHD.
Subjects who have had changes in the dosage or type of their medication(s) for anxiety, depression, and/or ADHD within 3 months of enrollment.
Subjects who have scheduled or planned medication and/or medication dose changes during the study period. These medication changes include the initiation of a new medication, discontinuation of a medication, modification of medication dose, and/or the route of administration of a medication.
Subjects who are taking benzodiazepines and/or beta blockers
* History of kidney disease or hyperkalemia
* Subject has received an investigational drug within 30 days prior to signing consent
* Erectile dysfunction
* Has any condition (e.g., psychiatric illness) or situation that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's ability to adhere with study procedures
* Currently undergoing treatment for Peyronie's Disease
* Abnormal Testosterone or Thyroid Stimulating Hormone level
* Treated hypogonadism or hypothyroidism
* Planned travel during the study
* The subject is trans-gender
* History of substance abuse in the last 12 months
* Illicit drug use, smoking, or vaping within 4 weeks
* Upper respiratory illness within two weeks on screening
* If profession requires being on call, no overnight or on call duties during the study
* Subject reports any communicable skin or venereal disease
* Subject reports rash or lesion on the penis or surrounding area.
* STOP-Bang score \> 2
* Having the diagnosis of Restless Leg Syndrome.
* Having insomnia as defined by: Subject with insomnia would have difficulty initiating or maintaining sleep (30 minutes or more at sleep initiation or 30 minutes or more to fall back asleep if wakes during the night). The above occurs at least 3 times per week for at least 1 month. Furthermore, there must be adequate opportunity for sleep and there must be associated morbidity (feels tired during the day). Definition based on: The International Classification of Sleep Disorders - Third Edition (ICSD-3), 2014.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT04349059
Study Brief:
Protocol Section:
NCT04349059