NCT02747719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

April 18, 2016

Last Update Submit

July 9, 2018

Conditions

Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Subjective alertness

    8 days

Study Arms (1)

Light and exercise

EXPERIMENTAL

Exposure to light with exercise

Behavioral: Light and exercise

Interventions

Light and exerciseBEHAVIORAL

Exposure to light and exercise

Light and exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening
  • moderate-intensity exercise for at least 150 minutes per week

You may not qualify if:

  • color blind
  • no prescription medications, except hormonal birth control in females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

LightExercise

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, NonionizingMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elizabeth B Klerman, MD PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 22, 2016

Study Start

April 1, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

US(1)