NCT02978053

Brief Summary

This project examines 1) the effects of appropriately timed bright light on adaptation (in terms of sleep and sleepiness) to three consecutive night shifts; and 2) the effects of such bright light on re-adaptation (in terms of sleep and sleepiness) to a day-oriented schedule after the night shift period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

November 25, 2016

Last Update Submit

October 1, 2019

Conditions

Shift-Work Sleep Disorder

Keywords

Bright lightSleepinessSleepPsychomotor vigilance

Outcome Measures

Primary Outcomes (1)

  • Sleepiness during the night shifts

    Self-reported using the Karolinska Sleepiness Scale (KSS)

    3 days

Secondary Outcomes (5)

  • Psychomotor vigilance during night shifts

    3 days

  • Sleep after the night shifts

    3 days

  • Sleepiness during the days after the night shift period

    3 days

  • Sleep during the days after the night shift period

    3 days

  • Functioning on each shift, and shift period in total, compared to under normal conditions

    6 days

Study Arms (2)

Bright light

EXPERIMENTAL

10 000 lux

Behavioral: Bright light

Red light

PLACEBO COMPARATOR

400 lux

Behavioral: Red light

Interventions

Bright lightBEHAVIORAL

Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).

Bright light
Red lightBEHAVIORAL

Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).

Red light

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A rotating shift work schedule involving three days without night shifts, followed by three consecutive night shifts, followed by three days without night shifts
  • Problems with sleepiness during night shifts

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmSleepiness

Interventions

Red Light

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Bjørn Bjorvatn, MD, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 2, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)