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

April 24, 2023 updated by: Randi Liset, University of Bergen

Nightly Light Exposure in Pregnancy: Blue-blocking Glasses as an Intervention to Ease Sleep Disturbances and to Improve Mood

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Several hormonal and mechanical influences can cause insomnia in pregnancy, and insomnia has been reported by 62% of pregnant women, a number that is significantly higher than found in the general population (10-15%). Disrupted sleep among pregnant women also includes nocturia (a frequent need to get up and urinate at night), dyspnea (shortness of breath), nasal congestion, muscular aches and pelvic pains, fetal activity, leg cramps as well as reflux.

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5232
        • Randi Liset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • nulliparous women
  • 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:

  • somatic or psychiatric disorders
  • fever and other health conditions affecting sleep
  • working at night during the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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%.
Device: Blue-blocking glasses
Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Other Names:
  • Virtual darkness eyewear, orange glasses
Active Comparator: 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%.
Device: 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 Names:
  • Grey sunglasses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep diary
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Daily subjective estimates of sleep variables, and will be assessed every morning.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Change in motor activity measured by using Actigraphy.
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Objective measure by Actiwatch Spectrum from Philips Respironics. The participants will use the Actiwatch for the whole study period of three weeks.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Melatonin level
Time Frame: 2 weeks in the third trimester of pregnancy, mainly gestational week 29-31
Measured by saliva samples.
2 weeks in the third trimester of pregnancy, mainly gestational week 29-31

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bergen Insomnia Scale (BIS)
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
The BIS measure subjective symptoms of insomnia during the previous week, and will be assessed at day 1 and day 21 of the study period.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Karolinska Sleepiness Scale (KSS)
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measure subjective sleepiness just prior to turning the lights off, and will be assessed every evening in the study period.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Evening activation
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measured subjectively by the Pre-Sleep Arousal Scale (PSAS).
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Sleepiness (subjectively)
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measured by the Epworth Sleepiness Scale (ESS).
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Mood
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measured by the self-report forms Positive and Negative Affect Schedule.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
The Beck Anxiety Inventory (BAI)
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measure subjective symptoms of anxiety, and will be assessed at day 1 and day 21 of the study period.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
The Beck Depression Inventory-II (BAI-II)
Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measure subjective symptoms of depression during the last week, and will be assessed at day 1 and day 21 of the study period.
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Western Norway University of Applied Sciences
The Norwegian Competence Center for Sleep Disorders (SOVno)

Investigators

  • Principal Investigator: Randi Liset, PhD student, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

April 9, 2019

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/1394/REK vest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: This is a brief description of the Project published at the web site of The Regional Ethics Committee (REC West).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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