SleepGoldilocksNCT04804124
Sleep Duration and Cardiovascular Health
A study testing Regularized Sleep Schedule in people with Sleep and Cardiovascular Risk Factor, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Cardiovascular Risk Factor
- What is being tested?
- Regularized Sleep Schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ages 25-65y
- Lean and overweight (BMI 18.5-40 kg/m2)
- No acute, chronic, or debilitating medical conditions
- No prescription/non-prescription medications or drugs of abuse
- Current non-smoker (tobacco and marijuana)
- Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, and additional sleep and health profiling questionnaires may be eligible to participate.
Who cannot join
- Persons with any acute, chronic, or debilitating medical condition except pre-hypertension will be excluded.
- Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.
- Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.
- Persons with a history of regular night/or rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.
- Pregnant women, decisionally impaired adults, and prisoners will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Saurabh S Thosar, PhD, 503-494-2064, clinphys@ohsu.edu
Saurabh S Thosar, PhD
About this study
This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that vascular endothelial function in the brachial artery, and other associated cardiovascular risk markers are impaired in short sleepers and long sleepers as compared to the control group of average duration sleepers.
To test the hypothesis that the optional intervention to maintain an 8-hour per night sleep schedule will alleviate vascular endothelial function impairment.
OUTLINE:
Participants will measure sleep, physical activity, and blood pressure with at-home devices before coming in for one in-lab visit, where they will have vascular function and blood markers measured, as well as an optional CT scan to measure calcium in the coronary arteries. An optional intervention may occur after this: Participants will continue the at-home measures while maintaining a chosen regular 8-hour per night sleep schedule, before coming in for a second in-lab visit with all same measures except for CT scan.
- Conditions
- Sleep, Cardiovascular Risk Factor
- Being tested
- Regularized Sleep Schedule
- Keywords
- cardiovascular, sleep duration, vascular endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regularized Sleep ScheduleBehavioural
Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Short Sleepers | Experimental | Reported nightly sleep time of ≤6 hours Receives: Behavioral: Regularized Sleep Schedule |
| Long Sleepers | Experimental | Reported nightly sleep time of ≥9 hours Receives: Behavioral: Regularized Sleep Schedule |
| Average Duration Sleepers | Experimental | Reported nightly sleep time of 7-8 hours Receives: Behavioral: Regularized Sleep Schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Endothelial Function
Investigators will measure endothelial function as flow-mediated dilation.
Measured: 2 weeks
Blood pressure
Blood pressure (systolic and diastolic) will be measured in a supine position in the dominant arm.
Measured: 2 weeks
Sleep duration
Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start9 Jun 2021
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Thosar, Oregon Health and Science University
- Investigators
- Saurabh S Thosar, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804124
- Sponsor's protocol ID
- 00021448
- Acronym
- Goldilocks
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Duration and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04804124
- Acronym / sponsor ID
- Goldilocks / 00021448
- Conditions
- Sleep, Cardiovascular Risk Factor
- Keywords
- cardiovascular, sleep duration, vascular endothelial function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- 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.
This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.
Detailed description
PRIMARY OBJECTIVES:
- To test the hypothesis that vascular endothelial function in the brachial artery, and other associated cardiovascular risk markers are impaired in short sleepers and long sleepers as compared to the control group of average duration sleepers.
To test the hypothesis that the optional intervention to maintain an 8-hour per night sleep schedule will alleviate vascular endothelial function impairment.
OUTLINE:
Participants will measure sleep, physical activity, and blood pressure with at-home devices before coming in for one in-lab visit, where they will have vascular function and blood markers measured, as well as an optional CT scan to measure calcium in the coronary arteries. An optional intervention may occur after this: Participants will continue the at-home measures while maintaining a chosen regular 8-hour per night sleep schedule, before coming in for a second in-lab visit with all same measures except for CT scan.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short Sleepers | Experimental | Behavioral: Regularized Sleep ScheduleReported nightly sleep time of ≤6 hours |
| Long Sleepers | Experimental | Behavioral: Regularized Sleep ScheduleReported nightly sleep time of ≥9 hours |
| Average Duration Sleepers | Experimental | Behavioral: Regularized Sleep ScheduleReported nightly sleep time of 7-8 hours |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 25-65y
- Lean and overweight (BMI 18.5-40 kg/m2)
- No acute, chronic, or debilitating medical conditions
- No prescription/non-prescription medications or drugs of abuse
- Current non-smoker (tobacco and marijuana)
Key exclusion criteria (5 listed)
- Persons with any acute, chronic, or debilitating medical condition except pre-hypertension will be excluded.
- Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.
- Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.
- Persons with a history of regular night/or rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.
- Pregnant women, decisionally impaired adults, and prisoners will be excluded.
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 |
|---|---|---|
| Regularized Sleep ScheduleParticipants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention. | Behavioural | Average Duration Sleepers, Long Sleepers, Short Sleepers |
Primary outcome
Vascular Endothelial Function
Time frame: 2 weeks
Investigators will measure endothelial function as flow-mediated dilation.
Blood pressure
Time frame: 2 weeks
Blood pressure (systolic and diastolic) will be measured in a supine position in the dominant arm.
Sleep duration
Time frame: 2 weeks
Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Saurabh S Thosar, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regularized Sleep Schedule in people with Sleep and Cardiovascular Risk Factor, run by Oregon Health and Science University 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Chaudhary, MPH (5034942064, burkeni@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Endothelial Function (time frame: 2 weeks). 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 4 Aug 2026.