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Sleep and Circadian Interventions for High Blood Pressure
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
Ages 25-64
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 nights
Awards & highlights
Study Summary
This trial looks at how sleep and the body's natural 24-hour clock affects blood pressure in people with hypertension.
Who is the study for?
This trial is for adults aged 25-64 with a BMI of 18.5-42kg/m2 and hypertension, having an average resting BP between 130/80 mmHg and 160/100 mmHg. Excluded are heavy smokers, recent shift workers, frequent travelers across time zones, those on certain meds or with drug/alcohol issues, pregnant women, individuals with severe cardiovascular or psychological conditions, and those with serious sleep disorders.Check my eligibility
What is being tested?
The study examines how the body's circadian rhythm (24-hour cycle) and sleep quality affect blood pressure in hypertensive patients. Participants will undergo various trials including a Circadian Protocol to assess their natural rhythms, Overnight Sleep Trial monitored by polysomnography at home to evaluate sleep patterns, Rested Wakefulness Trial to observe alertness levels after restful sleep, and adherence to a Regularized Sleep Schedule.See study design
What are the potential side effects?
Since this trial involves non-invasive monitoring rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing monitoring equipment during sleep studies or potential disruption of normal sleeping patterns due to the regularized schedule.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 25 and 64 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-2 nights
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 nights
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aldosterone (Circadian and Overnight sleep vs. rested wakefulness trial)
Blood pressure (Circadian and Overnight sleep vs. rested wakefulness trial)
Epinephrine (Circadian and Overnight sleep vs. rested wakefulness trial)
+9 moreSecondary outcome measures
Ambulatory blood pressure (Sleep regularization trial)
Blood pressure dipping status (Sleep regularization trial)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dipping vs non-dipping HTNExperimental Treatment5 Interventions
Participants will wear an ambulatory blood pressure monitor (SpaceLabs, Inc.) which will take their blood pressure in 20-30-minute intervals for 24-48 hours to determine blood pressure dipping status.
All participants in this arm will complete the experiments in this order:
At-home polysomnography;
Constant Routine protocol;
Rested Wakefulness Trial AND Overnight Sleep Trial (Randomized crossover);
Sleep Regularization Trial
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,880 Total Patients Enrolled
Saurabh S Thosar, PhDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
122 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not used cannabis for 30 days before the study.I am between 25 and 64 years old.Your body mass index (BMI) is between 18.5 and 42.I have a severe sleep disorder.I have no chronic diseases affecting my health outcomes, except for high blood pressure.You have worked night shifts in the past year before the study.I have a history of heart issues, including heart failure or surgery.You have smoked a lot over the years, about a pack a day for 5 years or more.I am only taking contraceptives or blood pressure medicine.You have a history of using illegal drugs or being dependent on alcohol.My average blood pressure is between 130/80 and 160/100.You have a history of mental health conditions.You have traveled across three or more time zones for at least three months.Your blood pressure is higher than 160/100 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: Dipping vs non-dipping HTN
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.
Does this study require participants to be adults?
"As per the inclusion criteria listed on the study, patients that can enroll are aged 25 to 64. There are 115 other trials for patients younger than 25 and 1168 for seniors."
Answered by AI
Are recruitment efforts still underway for this experiment?
"Indeed, the clinical trial is currently looking for participants, as shown by the data on clinicaltrials.gov. This study was originally posted on 6/1/2022 and edited on 9/26/2022. 1 centre is looking for 32 individuals to take part in this experiment."
Answered by AI
How many men and women are currently enrolled in this trial?
"The data available on clinicaltrials.gov show that this study is currently looking for patients to enroll. This trial was first posted on June 1st, 2022 and was most recently updated on September 26th, 2022. A total of 32 patients are needed at 1 trial site."
Answered by AI
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