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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03114072
• Other study ID #: 2016/1394/REK vest
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: July 2026

Study information

• Verified date: April 2023
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2026
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Randi Liset	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	The Norwegian Competence Center for Sleep Disorders (SOVno), Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Melatonin level	Measured by saliva samples.	2 weeks in the third trimester of pregnancy, mainly gestational week 29-31
Secondary	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
Secondary	Karolinska Sleepiness Scale (KSS)	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
Secondary	Evening activation	Measured subjectively by the Pre-Sleep Arousal Scale (PSAS).	3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Secondary	Sleepiness (subjectively)	Measured by the Epworth Sleepiness Scale (ESS).	3 weeks in the third trimester of pregnancy, mainly gestational week 28-31
Secondary	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
Secondary	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
Secondary	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