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| Name | Class |
|---|---|
| The Norwegian Competence Center for Sleep Disorders (SOVno) | UNKNOWN |
| Western Norway University of Applied Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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%. |
|
| 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue-blocking glasses | Device | Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | 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. | 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 | Measured by saliva samples. | 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 |
| Karolinska Sleepiness Scale (KSS) |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant human beings are female.
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| Name | Affiliation | Role |
|---|---|---|
| Randi Liset, PhD | University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Randi Liset | Bergen | 5232 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24144530 | Background | 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. | |
| 2265922 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 16, 2025 | |
| Reset | Jan 7, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 16, 2025 | Jan 7, 2026 |
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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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.
|
| Light grey control glasses | Device | Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night. |
|
|
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 | Measured subjectively by the Pre-Sleep Arousal Scale (PSAS). | 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 |
| Sleepiness (subjectively) | Measured by the Epworth Sleepiness Scale (ESS). | 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. | 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. | 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. | 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. | 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. | 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 | 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 |
| Background | AMERICAN ACADEMY OF SLEEP MEDICINE 2014. International classification of sleep disorders Darien, IL: American Academy of Sleep Medicine, 3. |
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| Background | BECK, A. T., STEER, R. A. & BROWN, G.A. 1996. Manual for the Beck Depression Inventory-II. San Antonio, TX:Psychological Corporation. |
| 19329259 | Background | 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. |
| 17351786 | Background | 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. |
| 11487664 | Background | Brainard 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. |
| 20030543 | Background | 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. |
| 22294820 | Background | 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. |
| 6668417 | Background | 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. |
| 22742434 | Background | 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. |
| 20027038 | Background | 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. |
| 27448477 | Background | 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. |
| 21297977 | Background | 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. |
| 25264124 | Background | 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. |
| 1798888 | Background | 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. |
| 2076086 | Background | 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. |
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| 4004706 | Background | 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. |
| 23855316 | Background | 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. |
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| Background | RØYSAMB, E., VITTERSØ, J. & TAMBS, K. 2014. The Relationship Satisfaction scale-psychometric properties. Norsk Epidemiologi, 24, 187-94. |
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| 21299507 | Background | 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. |
| 35089982 | Derived | 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. |
This is a brief description of the Project published at the web site of The Regional Ethics Committee (REC West). |
| D020920 | Dyssomnias |