PhysiologyNCT02839070
Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood
A study testing Sleep/Wake Schedule in people with Physiology, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiology
- What is being tested?
- Sleep/Wake Schedule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- BMI between 18.5 and 29.5
Who cannot join
- medications
- recent night-work, shift-work, or travel across >2 time zones
- use of medications
- pregnant or within 6 months post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.
- Conditions
- Physiology
- Being tested
- Sleep/Wake Schedule
- Keywords
- Sleep, Learning, Circadian Rhythms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep/Wake ScheduleOther
Timing of sleep and wake
| Study group | Role | What they receive |
|---|---|---|
| Regular Schedule | Experimental | Participant will be on a regular sleep/wake schedule Receives: Other: Sleep/Wake Schedule |
| Irregular Schedule | Experimental | Participant will be on an irregular sleep/wake schedule Receives: Other: Sleep/Wake Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian phase
Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment
Measured: 27 days
Learning
Sleep-dependent learning at 3-4 times during inpatient portion of the experiment
Measured: 27 days
Mood
Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment
Measured: 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2021
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhysiologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Klerman MD PhD, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839070
- Sponsor's protocol ID
- R01HL128538
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2016
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood
- ClinicalTrials.gov ID
- NCT02839070
- Acronym / sponsor ID
- R01HL128538
- Conditions
- Physiology
- Keywords
- Sleep, Learning, Circadian Rhythms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 20 Jul 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.
The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Schedule | Experimental | Other: Sleep/Wake ScheduleParticipant will be on a regular sleep/wake schedule |
| Irregular Schedule | Experimental | Other: Sleep/Wake ScheduleParticipant will be on an irregular sleep/wake schedule |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- BMI between 18.5 and 29.5
Key exclusion criteria (4 listed)
- medications
- recent night-work, shift-work, or travel across >2 time zones
- use of medications
- pregnant or within 6 months post-partum
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 |
|---|---|---|
| Sleep/Wake ScheduleTiming of sleep and wake | Other | Irregular Schedule, Regular Schedule |
Primary outcome
Circadian phase
Time frame: 27 days
Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment
Learning
Time frame: 27 days
Sleep-dependent learning at 3-4 times during inpatient portion of the experiment
Mood
Time frame: 27 days
Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Physiology
Active, not recruiting
Adipocyte-Derived Extracellular Vesicles, Weight Loss, and Endothelial Function
Obesity, Weight Loss
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
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
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep/Wake Schedule in people with Physiology, 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 4 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 20 Jan 2026. 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: 27 days). The study lists 3 primary outcomes in all. 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 20 Jan 2026.