Effects of Light and Exercise on Human Circadian Rhythms... | NCT02747719

Studies
Effects of Light and Exercise on Human Circadian Rhythms and Performance

NCT02747719

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Jul 11, 2018Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Circadian Rhythm

Interventions

Light and exercise

Countries

United States

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

Jul 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

Apr 2016Actual

Primary Completion Date

May 31, 2017Actual

Completion Date

May 31, 2018Actual

First Submitted Date

Apr 18, 2016

First Submission Date that Met QC Criteria

Apr 19, 2016

First Posted Date

Apr 22, 2016Estimated

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

Jul 9, 2018

Last Update Posted Date

Jul 11, 2018Actual

Name	Class
NSBRI	UNKNOWN

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

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.

Detailed Description

Not provided

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

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Light and exercise	Experimental	Exposure to light with exercise	Behavioral: Light and exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Light and exercise	Behavioral	Exposure to light and exercise	Light and exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Subjective alertness	Subjective alertness will be measured using the change in values on standardized mood scales on different days of the protocol.	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth B Klerman, MD PhD	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008027	Light
D015444	Exercise

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided