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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02747719
Other study ID # HFP02802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date May 31, 2018

Study information

Verified date July 2018
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Both light and exercise are effective countermeasures for space and ground-based crews for circadian phase resetting and alertness levels. The investigators propose to test the combined effects of these two countermeasures to determine whether adding exercise to light stimuli will further improve circadian phase resetting and alertness.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date May 31, 2018
Est. primary completion date May 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening

- moderate-intensity exercise for at least 150 minutes per week

Exclusion Criteria:

- color blind

- no prescription medications, except hormonal birth control in females

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Light and exercise
Exposure to light and exercise

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital NSBRI

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circadian Phase Circadian Phase will be measured using the change in timing of the melatonin rhythm on different days of the protocol. Melatonin will be assayed in blood and/or saliva. 8 days
Secondary Subjective alertness Subjective alertness will be measured using the change in values on standardized mood scales on different days of the protocol. 8 days
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