Sleep apnea testosterone study pulled before starting
NCT ID NCT01850992
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study was designed to understand how obstructive sleep apnea (OSA) speeds up the natural drop in testosterone as men age. Researchers planned to use CPAP machines—one real, one placebo—to test hormone changes in men aged 30 to 70 with moderate to severe OSA. However, the study was withdrawn before enrolling any participants, so no data or conclusions are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Start date
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May 2013
- Finished
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Aug 2015
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 70 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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LA Biomedical Research Institute
Torrance, California, 90502, United States
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