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Regularized Sleep Schedule for Cardiovascular Risk (Goldilocks Trial)
N/A
Recruiting
Led By Saurabh S Thosar, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No acute, chronic, or debilitating medical conditions
No prescription/non-prescription medications or drugs of abuse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Goldilocks Trial Summary
This trial will study how different sleep duration affects cardiovascular health, physical activity, and sleep quality. It will compare short sleepers (6 hrs or less), long sleepers (9 hrs or more), and people who sleep an average amount (7-8 hrs). The optional intervention will have participants sleep 8 hrs per night for one week.
Who is the study for?
This trial is for men and women aged 25-65 who don't smoke, have a BMI of 18.5-40, aren't on any medications or drugs, and don't have chronic health issues. It's not for those with recent shift work, extensive travel history, pregnant women, prisoners, or people with severe psychiatric conditions.Check my eligibility
What is being tested?
The study looks at how different sleep durations affect heart health by observing three groups: short sleepers (≤6 hrs), long sleepers (≥9 hrs), and average sleepers (7-8 hrs). Participants can choose to follow an 8-hour nightly sleep schedule for one week as part of the intervention.See study design
What are the potential side effects?
Since this trial involves adopting a regularized sleep schedule without medication use, there are no direct side effects from interventions like you might expect with drug trials.
Goldilocks Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have any severe or long-term health conditions.
Select...
I am not taking any prescription, non-prescription drugs, or drugs of abuse.
Select...
I am between 25 and 65 years old.
Goldilocks Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24-hour BP measurement
Blood Cholesterol
Blood cortisol
+17 moreGoldilocks Trial Design
3Treatment groups
Experimental Treatment
Group I: Short SleepersExperimental Treatment1 Intervention
Reported nightly sleep time of ≤6 hours
Group II: Long SleepersExperimental Treatment1 Intervention
Reported nightly sleep time of ≥9 hours
Group III: Average Duration SleepersExperimental Treatment1 Intervention
Reported nightly sleep time of 7-8 hours
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
7,385,700 Total Patients Enrolled
6 Trials studying Cardiovascular Risk
1,570 Patients Enrolled for Cardiovascular Risk
Saurabh S Thosar, PhDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
42 Total Patients Enrolled
2 Trials studying Cardiovascular Risk
42 Patients Enrolled for Cardiovascular Risk
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not smoke tobacco or marijuana currently.I do not have any serious or long-term health conditions, except for slightly high blood pressure.My BMI is between 18.5 and 40.People who fit all the criteria above, have a suitable medical history and health habits, and answer additional sleep and health questions may be eligible to participate.I do not have any severe or long-term health conditions.I am not taking any prescription, non-prescription drugs, or drugs of abuse.You have a history of serious mental health issues or disorders.I am between 25 and 65 years old.I do not have symptoms like fever or signs of infection.
Research Study Groups:
This trial has the following groups:- Group 1: Average Duration Sleepers
- Group 2: Long Sleepers
- Group 3: Short Sleepers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research endeavor ongoing?
"The trial is open for enrollment, as indicated on clinicaltrials.gov; this medical research was first posted to the website on June 9th 2021 and last updated on August 10th 2022."
Answered by AI
Does the eligibility criteria for this trial encompass individuals under 20 years of age?
"Patients wishing to take part in this medical trial must be between 25 and 65 years of age, as per the stated conditions for eligibility."
Answered by AI
How many participants are actively engaged in this experiment?
"Correct. As evidenced on clinicaltrials.gov, this medical research has been accepting applications since June 9th 2021 and remains open to new participants as of August 10th 2022. In total, 112 patients are needed across a single centre."
Answered by AI
Is individual involvement in this experiment feasible?
"112 participants are necessary for this sleep trial, and the eligibility criteria stipulates that patients must be between 25 and 65 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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