Sleep DisturbanceNCT03114072
Blocking Blue Light in Pregnancy, Effects on Melatonin Profile and Sleep
A study testing Blue-blocking glasses in people with Sleep Disturbance, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Blue-blocking glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 6 Jun 2017to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- somatic or psychiatric disorders
- fever and other health conditions affecting sleep
- working at night during the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Disturbance
- Being tested
- Blue-blocking glasses, Light grey control glasses
- Keywords
- Pregnancy, Blue-blockers, Sleep quality, Melatonin
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue-blocking glassesDevice
Also called Virtual darkness eyewear, orange 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 glassesDevice
Also called Grey sunglasses
Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
| Study group | Role | What they receive |
|---|---|---|
| Blue-blocking glasses | Active comparator | 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%. Receives: Device: Blue-blocking glasses |
| Light grey control glasses | Active comparator | 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%. Receives: Device: Light grey control glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep diary
Daily subjective estimates of sleep variables, and will be assessed every morning.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
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.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Melatonin level
Measured by saliva samples.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Secondary outcomes (10)
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.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Karolinska Sleepiness Scale (KSS)
Measure subjective sleepiness just prior to turning the lights off, and will be assessed every evening in the study period.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Evening activation
Measured subjectively by the Pre-Sleep Arousal Scale (PSAS).
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Sleepiness (subjectively)
Measured by the Epworth Sleepiness Scale (ESS).
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Mood
Measured by the self-report forms Positive and Negative Affect Schedule.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
The Beck Anxiety Inventory (BAI)
Measure subjective symptoms of anxiety, and will be assessed at day 1 and day 21 of the study period.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
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.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Common pregnancy complaints Questionnaire
Measure subjective complaints during the last night, assessed every morning of the study period.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Cortisol level
Measured by saliva samples, assessed at day 7 and day 21 of the study period.
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Alpha Amylase level
Measured by saliva samples, assessed at day 7 and day 21 of the study period
Measured: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start6 Jun 2017
- Primary completion9 Apr 2019
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences
- Responsible party
- Principal investigator, Randi Liset, University of Bergen
- Investigators
- Randi Liset, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114072
- Sponsor's protocol ID
- 2016/1394/REK vest
- Status last verified
- Dec 2024
- First submitted
- 24 Mar 2017
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24144530Akerstedt 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.
PubMed 2265922AMERICAN ACADEMY OF SLEEP MEDICINE 2014. International classification of sleep disorders Darien, IL: American Academy of Sleep Medicine, 3.
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.
PubMed 3204199BECK, A. T., STEER, R. A. & BROWN, G.A. 1996. Manual for the Beck Depression Inventory-II. San Antonio, TX:Psychological Corporation.
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.
PubMed 19329259Berson 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.
PubMed 17351786Brainard GC, Hanifin JP, Greeson JM, Byrne B, Glickman G, Gerner E, Rollag MD; New Collective Author. 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.
PubMed 11487664Burkhart 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.
PubMed 20030543Carney 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.
PubMed 22294820Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Dorheim 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.
PubMed 22742434Facco 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.
PubMed 20027038Gronli 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.
PubMed 27448477Hauge 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.
PubMed 21297977
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nightly Light Exposure in Pregnancy: Blue-blocking Glasses as an Intervention to Ease Sleep Disturbances and to Improve Mood
- ClinicalTrials.gov ID
- NCT03114072
- Acronym / sponsor ID
- 2016/1394/REK vest
- Conditions
- Sleep Disturbance
- Keywords
- Pregnancy, Blue-blockers, Sleep quality, Melatonin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue-blocking glasses | Active comparator | Device: Blue-blocking glassesN=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%. |
| Light grey control glasses | Active comparator | Device: Light grey control glassesN=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%. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- somatic or psychiatric disorders
- fever and other health conditions affecting sleep
- working at night during the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue-blocking glassesAlso: Virtual darkness eyewear, orange glassesWear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night. | Device | Blue-blocking glasses |
| Light grey control glassesAlso: Grey sunglassesWear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night. | Device | Light grey control glasses |
Primary outcome
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.
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.
Melatonin level
Time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Measured by saliva samples.
10 secondary outcomes
Bergen Insomnia Scale (BIS)
Time frame: 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
Evening activation
Time frame: 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
Mood
Time frame: 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
The Beck Depression Inventory-II (BAI-II)
Time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Common pregnancy complaints Questionnaire
Time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Cortisol level
Time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Alpha Amylase level
Time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 24144530Abbott 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.
- Background: PubMed 2265922Akerstedt 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.
- BackgroundAMERICAN ACADEMY OF SLEEP MEDICINE 2014. International classification of sleep disorders Darien, IL: American Academy of Sleep Medicine, 3.
- Background: PubMed 3204199Beck 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.
- BackgroundBECK, A. T., STEER, R. A. & BROWN, G.A. 1996. Manual for the Beck Depression Inventory-II. San Antonio, TX:Psychological Corporation.
- Background: PubMed 19329259Bennett 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.
- Background: PubMed 17351786Berson 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.
- Background: PubMed 11487664Brainard GC, Hanifin JP, Greeson JM, Byrne B, Glickman G, Gerner E, Rollag MD; New Collective Author. 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.
- Background: PubMed 20030543Burkhart 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.
- Background: PubMed 22294820Carney 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 22742434Dorheim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randi Liset, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue-blocking glasses in people with Sleep Disturbance, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary (time frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03114072, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.