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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT01850992
Eligibility Criteria:
Inclusion Criteria:
* Men aged 30-70 years
* Moderate to severe OSA defined as an apnea hypopnea index (AHI) ≥20 events/h and an oxygen desaturation index 3% ≥15 events/h.
* BMI of 30-35 kg/m2.
* Stable weight over preceding 6 weeks
* Not previously successfully treated with CPAP
* Living in the community
Exclusion Criteria:
* Unable or unwilling to provide written Institutional Review Board (IRB) -approved informed consent.
* Severe OSA requiring immediate CPAP treatment (severe OSA defined as AHI \>80 events/h or minimum oxygen saturation \<85%
* Excessive sleepiness in relation to the subject's occupation which thereby increases their associated risk in the physician's judgement (e.g. truck driver or transport worker)
* Sleepiness-related automobile accident in previous 12 months
* Diabetes mellitus (historically or based on screening Hemoglobin A1c \>6.5%)
* Patients with severe renal or hepatic impairment, in the judgement of the investigator. This may include patients with evidence of active liver disease (levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or alkaline phosphatase \>2x the upper limit of the normal range (ULN) and patients with impaired renal function as evidenced by a creatine value \> 1.2x ULN.
* Any chronic medical conditions likely, in the judgment of the investigator, that makes the patient unable to complete the study safely, or otherwise unsuitable for the study or that may interfere with or influence study treatment.
* Blood donation in the previous 8 weeks.
* Shift workers or patients with an irregular sleep/wake routine.
* Recent transmeridian travel (\>3 time zones in last 10 days).
* Use of psychoactive medications (within 5 biological half-lives of enrollment) \[acetaminophen, laxatives, antacids, thiazide diuretics, ACE inhibitor, and ophthalmic or skin ointments are allowable\]
* Recent or concurrent drug or alcohol abuse
* Psychiatric illness under treatment
* Anemia (hematocrit \< 38%)
* Major organ-system disease (pulmonary, gastrointestinal, cardiac, hepatic, renal, endocrine, metabolic or hematological)
* Acute or chronic inflammatory illness; AIDS and/or use of AIDS-related antiviral medications; profound fatigue or significant personal stress
* Unoperated obstructive uropathy, recurrent prostatitis, indeterminate prostatic nodularity, history or suspicion of cancer of the prostate gland or screening serum prostatic specific antigen (PSA) concentration \> 4 ng/mL
* Allergy to any proposed study medication
* Other endocrine abnormalities including hypothyroidism or adrenal failure; primary gonadal disease as indicated by serum LH or follicle stimulating hormone (FSH) concentration \> 10 or \> - IU/L, respectively, hyperprolactinemia indicated by prolactin \> 25 μg/L
* Administration of testosterone or anabolic steroids
* Concurrent participation in another research study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01850992
Study Brief:
Protocol Section:
NCT01850992