EFFECTS OF LIGHT THERAPY THROUGH THE EAR CANAL ON CIRCADIAN RHYTHMS OF MELATONIN, CORTISOL, SLEEP, MOOD, AND PERFORMANCE

Completed

• Conditions: circadian alignment; evening types; late chronotypes

• Registration Number: NL-OMON40844
• Lead Sponsor: Valkee Oy.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Healthy men and women ages between 18 and 40 years*
Late chronotypes (mid sleep on days off -sleep corrected > 5.38 according to the Dutch MCTQ, 15% most late types)
Social jetlag (difference between midsleep on workdays and days off), of at least 60 minutes
Sleep duration is shorter on workdays than on days off
If subjects are allowed to sleep at the time they choose, they have no sleep complaints
Subjects are motivated to phase advance their sleep times
For female candidates, if in their reproductive age, they should be using a hormonal form of birth control
Subjects should be fluent in Dutch (because of the use of Dutch rating scales)
Signed informed consent
In possession of a smart phone

Exclusion Criteria

A (chronic) disease (physical or psychological)
low or high blood pressure
ear infection
mood disorder
a sleep disorder, mild sleep complaints are allowed
visually impaired or if they had undergone eye surgery in the last year (contact lenses and glasses are not a problem)
taking medication or have taken long-term effects medication in the 3 months prior to participation, which are known to increase the sensitivity to light
hypersensitivity to light as a consequence of a disease, e.g. epilepsy
regular use of sleep medication, stimulants, antidepressants, or anti-malaria tablets
Two or more time zones transmeridian flights one month prior to participation
Shift work during the 3 months prior to participation
Colour blindness
Excessive daily amounts of caffeinated drinks
Alcohol or drug problems
Being pregnant
parallel use of any other bright light device
use of transcranial light device in the past

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>timing and quality of the rhythms of sleep, several physiological rhythms and<br /><br>alertness</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>