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

NCT03114072 | Active Not Recruiting

• 1 other identifier: 2016/1394/REK vest
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance

Keywords

Pregnancy; Blue-blockers; Sleep quality; Melatonin

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Bergen Insomnia Scale (BIS)

  3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

• Karolinska Sleepiness Scale (KSS)

  3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

• Evening activation

  3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

• Sleepiness (subjectively)

  3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

• Mood

  3 weeks in the third trimester of pregnancy, mainly gestational week 28-31

Study Arms (2)

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%.

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%.

Device: Light grey control glasses

Interventions

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.

Also known as: Virtual darkness eyewear, orange glasses

Blue-blocking glasses

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.

Also known as: Grey sunglasses

Light grey control glasses

Eligibility Criteria

• Gender Eligibility Details: Pregnant human beings are female.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bergen: lead
• The Norwegian Competence Center for Sleep Disorders (SOVno): collaborator
• Western Norway University of Applied Sciences: collaborator

Study Sites (1)

Randi Liset

Bergen, 5232, Norway

Location

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  PMID: 35089982 DERIVED

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Randi Liset, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 14, 2017
• Study Start: June 6, 2017
• Primary Completion: April 9, 2019
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)