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NCT04037605 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Sleep Restriction, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

Active
Registry status
Early Phase 1
Development phase
5
Enrollment target
1
Study location

NCT04037605: Active Early Phase 1 study of Sleep Restriction, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

NCT04037605 is a Early Phase 1 study of Sleep Restriction that is active but no longer recruiting, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 5 participants, below the 66-participant average among 4 other Sleep Restriction trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04037605, a Early Phase 1 study of Sleep Restriction, is active but no longer recruiting, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Cortisol is measured in blood every 10 minutes for a 5 hour period, at the beginning and at the end of 4 nights of sleep restriction. The average cortisol is the parameter of interest.

Conditions Studied

Sleep Restriction

Interventions

  • DRUG Ganirelix
  • DRUG Cosyntropin Injectable Product
  • DRUG Ketoconazole Pill (also known as nizoral)
  • DRUG Dexamethasone Pill
  • DRUG Dexamethasone injection

Study Locations (1)

California

  • Los Angeles Biomedical Research Institute - Torrance

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2020-02-09
Est. Completion 2026-06-24
Phase Early Phase 1
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

55 total trials

What the registry record for NCT04037605 still lists

NCT04037605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 66-participant average among 4 other Sleep Restriction trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Sleep Restriction appearing as the primary indexed condition, and to 5 interventions - of which Ganirelix is the first listed.

NCT04037605 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04037605 about?

NCT04037605 is a clinical study titled "Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women". 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 fun...

What is the current status of trial NCT04037605?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2020-02-09. Estimated completion is 2026-06-24.

What conditions does trial NCT04037605 study?

This clinical trial studies the following conditions: Sleep Restriction.

What interventions are being tested in trial NCT04037605?

The interventions under investigation include: Ganirelix (DRUG), Cosyntropin Injectable Product (DRUG), Ketoconazole Pill (also known as nizoral) (DRUG), Dexamethasone Pill (DRUG), Dexamethasone injection (DRUG).

Who is sponsoring clinical trial NCT04037605?

This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04037605 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT04037605, the US trial registry maintained by the National Library of Medicine. NCT04037605 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.