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Reproductive Aging and Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01850992
Recruitment Status : Withdrawn (This study is non-funded study and experienced difficulty in recruitment.)
First Posted : May 10, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

Brief Summary:
The purpose of this study is to identify the mechanism(s) by which OSA exacerbates the age-linked decline in systemic testosterone concentrations by conducting a randomized order sham-controlled crossover study that dynamically evaluates the entire hypothalamic-pituitary testicular axis across a wide age range.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Active CPAP Device: Sham CPAP Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Reproductive Aging and Obstructive Sleep Apnea
Study Start Date : May 2013
Estimated Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: ACtive CPAP
Continuous positive airway pressure (CPAP) to treat obstructive Sleep Apnea
Device: Active CPAP
Effective CPAP will be administered

Placebo Comparator: Sham CPAP
This is placebo CPAP
Device: Sham CPAP
This is placebo CPAP




Primary Outcome Measures :
  1. Hypothalamic Function [ Time Frame: 3 months ]
    Measured as the ganirelix-suppressed (analytically reconstructed) basal LH secretion.

  2. Pituitary function [ Time Frame: 3 months ]
    This is calculated as the mass of LH secreted following the exogenous GnRH stimulus. The degree of feedback unleashing is inferred by the degree of elevation of LH pulse frequency elicited by androgen withdrawal.

  3. Testicular Function [ Time Frame: 3 months ]
    This is measured as Leydig-cell sensitivity is defined by analytical reconstruction of rate of testosterone secretion achieved in response to the last two of six (pseudosteady-state) pulses of recombinant human LH.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850992


Locations
United States, California
LA Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Peter Y Liu, MD PhD LA Biomedical Research Institute

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01850992     History of Changes
Other Study ID Numbers: 20892-01
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Los Angeles Biomedical Research Institute:
Obstructive sleep apnea.
sleep
male hormones

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases