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van CCT (UK)

van CCT (UK)

The effects of light on thermal physiology, thermal comfort and alertness

- candidate number21724
- NTR NumberNTR5148
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-feb-2015
- Secondary IDsNL 49108.068.14  Medisch Ethische Commissie azM/UM
- Public TitleThe effects of light on thermal physiology, thermal comfort and alertness
- Scientific TitleThe effects of light on thermal physiology, thermal comfort and alertness
- ACRONYMLedther
- hypothesisLighting conditions, the intensity as well as the colour, influence thermophysiolgical responses and thermal comfort.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria• Caucasian volunteers
• Generally healthy
• Age: 18 to 30 years
• BMI: 20-25 kg/m2
• Fat percentage: 20-30%
• Using Microgynon 30 or levonorgestrel/ehinylestradiol
• Normal chronotype
- Exclusion criteria• Colour blindness
• Ocular pathologies
• Medication use
• Pregnancy
• Hypertension (systolic/diastolic blood pressure >140/90)
• Hypotension (systolic/diastolic blood pressure <90/60)
• General feeling of illness at day of experiment
• (History of) cardiovascular diseases
• Contraindications of the telemetric pill:
o In the presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease
o A history of disorders or impairment of the gag reflex
o Previous gastrointestinal surgery
o Hypo motility disorders of the gastrointestinal tract including but not limited to ileus
• Participants that do not want to be informed about accidental medical findings, which might occur during the study. If participants do not agree that they will be informed about unexpected medical findings, they cannot participate in the study.
• Employees of the research group “Thermu” are excluded from participation.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-nov-2014
- planned closingdate1-jul-2016
- Target number of participants48
- InterventionsDuring the experiments the lighting conditions vary in intensity (bright and dim light) and in colour (long wavelength and short wavelengths). Experiments will be done under mild warm, mild cold and thermo neutral temperatures.
- Primary outcomeThemal comfort and thermal sensation
Human energy expenditure
Core and Skin temperatures
- Secondary outcomeSkin conductance
Cardiovascular parameters
Blood parameters
- TimepointsSubjects are exposed to lighting conditions for 5 hours. The different lighting conditions are provided at different days. Each subject has to participate in two experimental days, and therefore will be exposed to two lighting exposures.
- Trial web site
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESPhD. Wouter Marken Lichtenbelt, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Philips Electronics Nederland B.V. Partnership Program “Advanced Sustainable Lighting Solutions”
- Publicationsnot applicable
- Brief summary
- Main changes (audit trail)
- RECORD26-feb-2015 - 10-jul-2017

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