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Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Minor Study completion date: Jul 24, 2024 to Jun 24, 2026v11
  2. Minor Re-verified, no change to tracked fieldsv10
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 5
    • Study completion date: Jul 24, 2023 to Jul 24, 2024
    • Site details revised
    v9
  4. Minor 2 versions Re-verified since Sep 8, 2020, no change to tracked fieldsv7-v8
  5. Minor Study completion date: Jul 24, 2022 to Jul 24, 2023
    • Start date changed from estimate of Feb 2020 to Feb 9, 2020
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Dec 14, 2019 to Feb 2020v5
  2. Notable Start date: Aug 14, 2019 to Dec 14, 2019v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Start date: Jul 24, 2019 to Aug 14, 2019
    • Interventions: Corticorelin (Drug), Cosyntropin Injectable Product (Drug), Dexamethasone Pill (Drug), Dexamethasone injection (Drug), Ganirelix (Drug)… to Corticorelin (also known as Acthrel) (Drug), Cosyntropin Injectable Product (Drug), Dexamethasone Pill (Drug), Dexamethasone injection…
    • Secondary endpoints revised (11)
    • Site contact updated
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction and 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
Trial Details
NCT Number NCT04037605
Lead Sponsor Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions
(from sponsor)
Sleep Restriction
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov