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Trial record 43 of 2096 for:    Symptoms | Parasomnias

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

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ClinicalTrials.gov Identifier: NCT03114072
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
Norwegian National Advisory Unit on Sleep Disorders (SOVno)
Western Norway University of Applied Sciences (HVL)
Information provided by (Responsible Party):
Randi Liset, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Device: Blue-blocking glasses Device: Light grey control glasses Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: Nightly Light Exposure in Pregnancy: Blue-blocking Glasses as an Intervention to Ease Sleep Disturbances and to Improve Mood
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Blue-blocking glasses
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
Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Other Name: Virtual darkness eyewear, orange glasses

Active Comparator: Light grey control glasses
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
Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
Other Name: Grey sunglasses




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Melatonin level [ Time Frame: 2 weeks in the third trimester of pregnancy, mainly gestational week 29-31 ]
    Measured by saliva samples.


Secondary Outcome Measures :
  1. Bergen Insomnia Scale (BIS) [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    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.

  2. Karolinska Sleepiness Scale (KSS) [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measure subjective sleepiness just prior to turning the lights off, and will be assessed every evening in the study period.

  3. Evening activation [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measured subjectively by the Pre-Sleep Arousal Scale (PSAS).

  4. Sleepiness (subjectively) [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measured by the Epworth Sleepiness Scale (ESS).

  5. Mood [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measured by the self-report forms Positive and Negative Affect Schedule.

  6. The Beck Anxiety Inventory (BAI) [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measure subjective symptoms of anxiety, and will be assessed at day 1 and day 21 of the study period.

  7. The Beck Depression Inventory-II (BAI-II) [ Time Frame: 3 weeks in the third trimester of pregnancy, mainly gestational week 28-31 ]
    Measure subjective symptoms of depression during the last week, and will be assessed at day 1 and day 21 of the study period.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant human beings are female.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114072


Contacts
Contact: Randi Liset Liset, PhD student +4741526879 Randi.Liset@online.no
Contact: Staale Pallesen, PhD +4755588842 Staale.Pallesen@uib.no

Locations
Norway
University of Bergen Recruiting
Christiesgate 12, Bergen, Norway, 5020
Sponsors and Collaborators
University of Bergen
Norwegian National Advisory Unit on Sleep Disorders (SOVno)
Western Norway University of Applied Sciences (HVL)
Investigators
Principal Investigator: Randi Liset, PhD student University of Bergen

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
This is a brief description of the Project published at the web site of The Regional Ethics Committee (REC West).

Publications:
AMERICAN ACADEMY OF SLEEP MEDICINE 2014. International classification of sleep disorders Darien, IL: American Academy of Sleep Medicine, 3.
BECK, A. T., STEER, R. A. & BROWN, G.A. 1996. Manual for the Beck Depression Inventory-II. San Antonio, TX:Psychological Corporation.
RØYSAMB, E., VITTERSØ, J. & TAMBS, K. 2014. The Relationship Satisfaction scale-psychometric properties. Norsk Epidemiologi, 24, 187-94.

Responsible Party: Randi Liset, Principal Investigator, University of Bergen
ClinicalTrials.gov Identifier: NCT03114072     History of Changes
Other Study ID Numbers: 2016/1394/REK vest
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Randi Liset, University of Bergen:
Pregnancy
Blue-blockers
Sleep quality
Melatonin

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Signs and Symptoms
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Methamphetamine
Melatonin
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Antioxidants
Protective Agents
Central Nervous System Depressants