Circadian RhythmNCT02747719
Effects of Light and Exercise on Human Circadian Rhythms and Performance
A study testing Light and exercise in people with Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm
- What is being tested?
- Light and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening
- moderate-intensity exercise for at least 150 minutes per week
Who cannot join
- color blind
- no prescription medications, except hormonal birth control in females
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Circadian Rhythm
- Being tested
- Light and exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light and exerciseBehavioural
Exposure to light and exercise
| Study group | Role | What they receive |
|---|---|---|
| Light and exercise | Experimental | Exposure to light with exercise Receives: Behavioral: Light and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days
Secondary outcomes (1)
Subjective alertness
Subjective alertness will be measured using the change in values on standardized mood scales on different days of the protocol.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion31 May 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NSBRI
- Responsible party
- Principal investigator, Elizabeth B. Klerman, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747719
- Sponsor's protocol ID
- HFP02802
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Light and Exercise on Human Circadian Rhythms and Performance
- ClinicalTrials.gov ID
- NCT02747719
- Acronym / sponsor ID
- HFP02802
- Conditions
- Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- NSBRI
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light and exercise | Experimental | Behavioral: Light and exerciseExposure to light with exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy by history, physical exam, laboratory studies of blood and urine, and psychological screening
- moderate-intensity exercise for at least 150 minutes per week
Key exclusion criteria (2 listed)
- color blind
- no prescription medications, except hormonal birth control in females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light and exerciseExposure to light and exercise | Behavioural | Light and exercise |
Primary outcome
Circadian Phase
Time frame: 8 days
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.
1 secondary outcome
Subjective alertness
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth B Klerman, MD PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light and exercise in people with Circadian Rhythm, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian Phase (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.