search
Back to results

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

Primary Purpose

Sleep Disturbance

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Blue-blocking glasses
Light grey control glasses
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance focused on measuring Pregnancy, Blue-blockers, Sleep quality, Melatonin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Randi Liset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Blue-blocking glasses

Light grey control glasses

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

Sleep diary
Daily subjective estimates of sleep variables, and will be assessed every morning.
Change in motor activity measured by using Actigraphy.
Objective measure by Actiwatch Spectrum from Philips Respironics. The participants will use the Actiwatch for the whole study period of three weeks.
Melatonin level
Measured by saliva samples.

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2017
Last Updated
April 24, 2023
Sponsor
University of Bergen
Collaborators
The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03114072
Brief Title
Blocking Blue Light in Pregnancy, Effects on Melatonin Profile and Sleep
Official Title
Nightly Light Exposure in Pregnancy: Blue-blocking Glasses as an Intervention to Ease Sleep Disturbances and to Improve Mood
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
Keywords
Pregnancy, Blue-blockers, Sleep quality, Melatonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Consenting participants will be randomized (by www.randomizer.org) to either intervention/control condition. The intervention- and control glasses will be covered in the same looking wrapping, done by a third person, which will blind the investigator as well.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blue-blocking glasses
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Light grey control glasses
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Device
Intervention Name(s)
Blue-blocking glasses
Other Intervention Name(s)
Virtual darkness eyewear, orange glasses
Intervention Description
Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Intervention Type
Device
Intervention Name(s)
Light grey control glasses
Other Intervention Name(s)
Grey sunglasses
Intervention Description
Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Primary Outcome Measure Information:
Title
Sleep diary
Description
Daily subjective estimates of sleep variables, and will be assessed every morning.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Change in motor activity measured by using Actigraphy.
Description
Objective measure by Actiwatch Spectrum from Philips Respironics. The participants will use the Actiwatch for the whole study period of three weeks.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Melatonin level
Description
Measured by saliva samples.
Time Frame
2 weeks in the third trimester of pregnancy, mainly gestational week 29-31
Secondary Outcome Measure Information:
Title
Bergen Insomnia Scale (BIS)
Description
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.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Karolinska Sleepiness Scale (KSS)
Description
Measure subjective sleepiness just prior to turning the lights off, and will be assessed every evening in the study period.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Evening activation
Description
Measured subjectively by the Pre-Sleep Arousal Scale (PSAS).
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Sleepiness (subjectively)
Description
Measured by the Epworth Sleepiness Scale (ESS).
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
Mood
Description
Measured by the self-report forms Positive and Negative Affect Schedule.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
The Beck Anxiety Inventory (BAI)
Description
Measure subjective symptoms of anxiety, and will be assessed at day 1 and day 21 of the study period.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Title
The Beck Depression Inventory-II (BAI-II)
Description
Measure subjective symptoms of depression during the last week, and will be assessed at day 1 and day 21 of the study period.
Time Frame
3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant human beings are female.
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi Liset, PhD student
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Randi Liset
City
Bergen
ZIP/Postal Code
5232
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24144530
Citation
Abbott SM, Attarian H, Zee PC. Sleep disorders in perinatal women. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):159-68. doi: 10.1016/j.bpobgyn.2013.09.003. Epub 2013 Oct 7.
Results Reference
background
PubMed Identifier
2265922
Citation
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
Results Reference
background
Citation
AMERICAN ACADEMY OF SLEEP MEDICINE 2014. International classification of sleep disorders Darien, IL: American Academy of Sleep Medicine, 3.
Results Reference
background
PubMed Identifier
3204199
Citation
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
Results Reference
background
Citation
BECK, A. T., STEER, R. A. & BROWN, G.A. 1996. Manual for the Beck Depression Inventory-II. San Antonio, TX:Psychological Corporation.
Results Reference
background
PubMed Identifier
19329259
Citation
Bennett S, Alpert M, Kubulins V, Hansler RL. Use of modified spectacles and light bulbs to block blue light at night may prevent postpartum depression. Med Hypotheses. 2009 Aug;73(2):251-3. doi: 10.1016/j.mehy.2009.01.049. Epub 2009 Mar 28.
Results Reference
background
PubMed Identifier
17351786
Citation
Berson DM. Phototransduction in ganglion-cell photoreceptors. Pflugers Arch. 2007 Aug;454(5):849-55. doi: 10.1007/s00424-007-0242-2. Epub 2007 Mar 10.
Results Reference
background
PubMed Identifier
11487664
Citation
Brainard GC, Hanifin JP, Greeson JM, Byrne B, Glickman G, Gerner E, Rollag MD. Action spectrum for melatonin regulation in humans: evidence for a novel circadian photoreceptor. J Neurosci. 2001 Aug 15;21(16):6405-12. doi: 10.1523/JNEUROSCI.21-16-06405.2001.
Results Reference
background
PubMed Identifier
20030543
Citation
Burkhart K, Phelps JR. Amber lenses to block blue light and improve sleep: a randomized trial. Chronobiol Int. 2009 Dec;26(8):1602-12. doi: 10.3109/07420520903523719.
Results Reference
background
PubMed Identifier
22294820
Citation
Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
Results Reference
background
PubMed Identifier
6668417
Citation
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Results Reference
background
PubMed Identifier
22742434
Citation
Dorheim SK, Bjorvatn B, Eberhard-Gran M. Insomnia and depressive symptoms in late pregnancy: a population-based study. Behav Sleep Med. 2012;10(3):152-66. doi: 10.1080/15402002.2012.660588.
Results Reference
background
PubMed Identifier
20027038
Citation
Facco FL, Kramer J, Ho KH, Zee PC, Grobman WA. Sleep disturbances in pregnancy. Obstet Gynecol. 2010 Jan;115(1):77-83. doi: 10.1097/AOG.0b013e3181c4f8ec.
Results Reference
background
PubMed Identifier
27448477
Citation
Gronli J, Byrkjedal IK, Bjorvatn B, Nodtvedt O, Hamre B, Pallesen S. Reading from an iPad or from a book in bed: the impact on human sleep. A randomized controlled crossover trial. Sleep Med. 2016 May;21:86-92. doi: 10.1016/j.sleep.2016.02.006. Epub 2016 Mar 2.
Results Reference
background
PubMed Identifier
21297977
Citation
Hauge ER, Berle JO, Oedegaard KJ, Holsten F, Fasmer OB. Nonlinear analysis of motor activity shows differences between schizophrenia and depression: a study using Fourier analysis and sample entropy. PLoS One. 2011 Jan 28;6(1):e16291. doi: 10.1371/journal.pone.0016291.
Results Reference
background
PubMed Identifier
25264124
Citation
Henriksen TE, Skrede S, Fasmer OB, Hamre B, Gronli J, Lund A. Blocking blue light during mania - markedly increased regularity of sleep and rapid improvement of symptoms: a case report. Bipolar Disord. 2014 Dec;16(8):894-8. doi: 10.1111/bdi.12265. Epub 2014 Sep 27.
Results Reference
background
PubMed Identifier
1798888
Citation
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
Results Reference
background
PubMed Identifier
2076086
Citation
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
Results Reference
background
PubMed Identifier
20484314
Citation
Milton K, Bull FC, Bauman A. Reliability and validity testing of a single-item physical activity measure. Br J Sports Med. 2011 Mar;45(3):203-8. doi: 10.1136/bjsm.2009.068395. Epub 2010 May 19.
Results Reference
background
PubMed Identifier
4004706
Citation
Nicassio PM, Mendlowitz DR, Fussell JJ, Petras L. The phenomenology of the pre-sleep state: the development of the pre-sleep arousal scale. Behav Res Ther. 1985;23(3):263-71. doi: 10.1016/0005-7967(85)90004-x. No abstract available.
Results Reference
background
PubMed Identifier
23855316
Citation
Nodine PM, Matthews EE. Common sleep disorders: management strategies and pregnancy outcomes. J Midwifery Womens Health. 2013 Jul-Aug;58(4):368-77. doi: 10.1111/jmwh.12004. Epub 2013 Jul 15.
Results Reference
background
PubMed Identifier
19235401
Citation
Pallesen S, Bjorvatn B, Nordhus IH, Sivertsen B, Hjornevik M, Morin CM. A new scale for measuring insomnia: the Bergen Insomnia Scale. Percept Mot Skills. 2008 Dec;107(3):691-706. doi: 10.2466/pms.107.3.691-706.
Results Reference
background
Citation
RØYSAMB, E., VITTERSØ, J. & TAMBS, K. 2014. The Relationship Satisfaction scale-psychometric properties. Norsk Epidemiologi, 24, 187-94.
Results Reference
background
PubMed Identifier
17068990
Citation
Sivertsen B, Omvik S, Havik OE, Pallesen S, Bjorvatn B, Nielsen GH, Straume S, Nordhus IH. A comparison of actigraphy and polysomnography in older adults treated for chronic primary insomnia. Sleep. 2006 Oct;29(10):1353-8. doi: 10.1093/sleep/29.10.1353.
Results Reference
background
PubMed Identifier
3397865
Citation
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Results Reference
background
PubMed Identifier
21299507
Citation
Wilson DL, Barnes M, Ellett L, Permezel M, Jackson M, Crowe SF. Decreased sleep efficiency, increased wake after sleep onset and increased cortical arousals in late pregnancy. Aust N Z J Obstet Gynaecol. 2011 Feb;51(1):38-46. doi: 10.1111/j.1479-828X.2010.01252.x. Epub 2010 Dec 7.
Results Reference
background
PubMed Identifier
35089982
Citation
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.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://helseforskning.etikkom.no/prosjekterirek/prosjektregister/prosjekt?p_document_id=742253&p_parent_id=755398&_ikbLanguageCode=n
Available IPD/Information Comments
This is a brief description of the Project published at the web site of The Regional Ethics Committee (REC West).

Learn more about this trial

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

We'll reach out to this number within 24 hrs