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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02216318
Other study ID # H-3-2013-085
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date December 2013

Study information

Verified date August 2018
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.

Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.

In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility Inclusion Criteria:

- age 65 to 85 years

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blue light


Locations

Country Name City State
n/a

Sponsors (9)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen AF Lightning, Albertslund Kommune, DTU Fotonik, Elforsk, Gate 21, Philips Healthcare, Statens Byggeforskningsinstitut, VISO systems

Outcome

Type Measure Description Time frame Safety issue
Other pupillometry the pupillary response to blue and red light the last day of each light period
Other melatonin timing of melatonin onset the last day of each light period
Other Questionnaire Questionnaire count 3 weeks
Primary Sleep length The mean of sleep length during the last week of each light period 1 week
Secondary actigraphy mean sleep efficiency during the last week in each light period 1 week
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