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Blocking Blue Light in Pregnancy, Effects on Melatonin Profile and Sleep

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Secondary endpoints: 7 to 10v8
  2. Minor Study completion date: Jun 2022 to Jul 2026v7
  3. Minor Study completion date: Aug 2021 to Jun 2022v6
  4. Minor Study completion date: Aug 2020 to Aug 2021
    • Study site revised
    • Collaborators revised (2)
    v5
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Mar 2019 to Apr 9, 2019
    • Site details revised
    v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2017 to Jun 6, 2017
    v3
  2. Minor Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sleep disturbances are common in pregnancy, and the incidence increases during the third trimester. Light and specially the blue wavelengths of light, is affecting sleep and the circadian rhythm. The main aim of this randomized controlled study is to investigate the effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood in pregnant women in the third trimester. The outcome measures assess sleep variables, alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and depression. In addition we want to measure the pregnancy related sleep problems, alcohol intake, physical activity and perceives stress in the study population, and the association with daily/nightly light exposure.
Trial Details
NCT Number NCT03114072
Lead Sponsor University of Bergen
Collaborators: The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences
Conditions
(from sponsor)
Sleep Disturbance
Related terms Parasomnias, Sleep Initiation and Maintenance Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov