NCT01850992

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

May 7, 2013

Last Update Submit

September 4, 2025

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea.sleepmale hormones

Outcome Measures

Primary Outcomes (3)

  • Hypothalamic Function

    Measured as the ganirelix-suppressed (analytically reconstructed) basal LH secretion.

    3 months

  • Pituitary function

    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 months

  • Testicular Function

    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.

    3 months

Study Arms (2)

ACtive CPAP

ACTIVE COMPARATOR

Continuous positive airway pressure (CPAP) to treat obstructive Sleep Apnea

Device: Active CPAP

Sham CPAP

PLACEBO COMPARATOR

This is placebo CPAP

Device: Sham CPAP

Interventions

Active CPAPDEVICE

Effective CPAP will be administered

ACtive CPAP
Sham CPAPDEVICE

This is placebo CPAP

Sham CPAP

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LA Biomedical Research Institute

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Peter Y Liu, MD PhD

    LA Biomedical Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 10, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

US(1)