Blocking Blue Light in Pregnancy, Effects on Melatonin Profile and Sleep
NCT ID: NCT03114072
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2017-06-06
2026-07-31
Brief Summary
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Detailed Description
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Artificial light in the evening and during the night increases alertness, disturbs sleep, shifts the timing of the circadian clock and impairs the brains' restorative slow waves during deep sleep. Recent studies have however shown that use of BB-glasses in the evening improves sleep quality (subjectively reported) among persons with insomnia, and prevent alertness caused by blue-light emitting screens which are part of devices such as smart-phones and tablets.
This project will contribute with new knowledge on how filtering nightly light exposure in pregnant women in their third trimester affects their sleep and mood. Importantly, the project initiates new research on a potential non-pharmacological treatment of sleep disturbances by blocking blue wavelengths of light in the evening and during nocturnal awakenings. Blue light is known to increase alertness through a recently described retinal receptor; the intrinsically photoresponsive retinal ganglion cell (IpRGC), specialized for detecting daytime light signal. This project is highly innovative and may have significant practical implications Due to the variety of aims and outcome measures, we plan to present the outcomes in separate articles.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Blue-blocking glasses
N=30 The Blue-blocking glasses (orange-tinted), which remove more than 99% of the blue wavelengths (wavelengths within the visible spectrum shorter than 530 nm). Luminous transmittance: 50%.
Blue-blocking glasses
Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Light grey control glasses
N=30 Partially blue blocking light grey glasses, blocking only about 50% of blue wavelengths (wavelengths within the visible spectra shorter than 530 nm). Luminous transmittance: 55%.
Light grey control glasses
Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Interventions
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Blue-blocking glasses
Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Light grey control glasses
Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* expecting one child
* being in the third trimester of a normal pregnancy
* able to wear an actigraph during daytime and nighttime
* able to fill out a questionnaire in Norwegian
Exclusion Criteria
* fever and other health conditions affecting sleep
* working at night during the study protocol
FEMALE
No
Sponsors
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The Norwegian Competence Center for Sleep Disorders (SOVno)
UNKNOWN
Western Norway University of Applied Sciences
OTHER
University of Bergen
OTHER
Responsible Party
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Randi Liset
Principal Investigator
Principal Investigators
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Randi Liset, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Locations
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Randi Liset
Bergen, , Norway
Countries
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References
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Liset R, Gronli J, Henriksen RE, Henriksen TEG, Nilsen RM, Pallesen S. A randomized controlled trial on the effects of blue-blocking glasses compared to partial blue-blockers on sleep outcomes in the third trimester of pregnancy. PLoS One. 2022 Jan 28;17(1):e0262799. doi: 10.1371/journal.pone.0262799. eCollection 2022.
Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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2016/1394/REK vest
Identifier Type: -
Identifier Source: org_study_id