Energy-efficient and Health Promoting Light for Elderly P... | NCT02216318

Studies
Energy-efficient and Health Promoting Light for Elderly People

NCT02216318

Sponsor

Glostrup University Hospital, Copenhagen

Status

Completed

Last Update Posted

Aug 6, 2018Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Sleep

Interventions

blue light

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 12, 2014

First Submission Date that Met QC Criteria

Aug 12, 2014

First Posted Date

Aug 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2018

Last Update Posted Date

Aug 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Line Kessel, MD, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Name	Class
Elforsk	UNKNOWN
Albertslund Kommune	UNKNOWN
Gate 21	UNKNOWN
DTU Fotonik

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
blue light	Other		Blue light red light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep length	The mean of sleep length during the last week of each light period	1 week

Secondary Outcomes

Measure	Description	Time Frame
actigraphy	mean sleep efficiency during the last week in each light period	1 week

Other Outcomes

Measure	Description	Time Frame
pupillometry	the pupillary response to blue and red light	the last day of each light period
melatonin	timing of melatonin onset	the last day of each light period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 65 to 85 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Line Kessel, MD	Glostrup University Hospital, Copenhagen	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095743	Blue Light

Ancestor Terms

ID	Term
D008027	Light
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided