NCT02216318

Brief Summary

to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

August 12, 2014

Last Update Submit

August 3, 2018

Conditions

Sleep

Keywords

sleepcircadianmelatoninepupil response

Outcome Measures

Primary Outcomes (1)

  • Sleep length

    The mean of sleep length during the last week of each light period

    1 week

Secondary Outcomes (1)

  • actigraphy

    1 week

Other Outcomes (3)

  • pupillometry

    the last day of each light period

  • melatonin

    the last day of each light period

  • Questionnaire

    3 weeks

Study Arms (2)

red light

PLACEBO COMPARATOR

red light during the whole day

Other: blue light

Blue light

ACTIVE COMPARATOR

Blue light during early day

Other: blue light

Interventions

blue lightOTHER
Blue lightred light

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 to 85 years

You may not qualify if:

  • Conditions which will interfere by the primary endpoint as evaluated by the medical doctor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Blue Light

Intervention Hierarchy (Ancestors)

LightElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

Study Officials

  • Line Kessel, MD

    Glostrup University Hospital, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 12, 2014

First Posted

August 13, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 6, 2018

Record last verified: 2018-08