Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2022-08-04
2028-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Dipping vs non-dipping HTN
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:
1. At-home polysomnography;
2. Constant Routine protocol;
3. Rested Wakefulness Trial AND Overnight Sleep Trial (Randomized crossover);
4. Sleep Regularization Trial
At-home Polysomnography
Participants will complete one night of unattended polysomnography in their home environment (SOMNOtouch RESP, SOMNOmedics America Inc., FL, USA).
Circadian Protocol
Participants will spend 4 days/3 nights in the laboratory to uncover circadian rhythms. After 2 nights for acclimatization and baseline measurements, participants will stay awake for 28 hours in dim light, constant temperature, and semi-recumbent posture. Participants will be provided with standardized snacks regularly. Polysomnography, core body temperature, sleep, finger oximetry, electrocardiogram (ECG), and beat-to-beat BP will (except microneurography) be measured throughout. Blood will be drawn every 2-4h to analyze catecholamines, renin activity, and aldosterone. All other measurements, including BP, heart rate (HR), and flow-mediated dilation will be performed regularly. Salivary samples will be collected every 2hrs (when awake) to analyze melatonin levels. A recovery sleep period will be provided and baseline testing procedures will be performed. Investigators may acquire direct recordings of sympathetic activity using microneurography.
Rested Wakefulness Trial
Participants will start wearing an ambulatory BP monitor upon admission. Participants will be instrumented with full polysomnography (except leg myogram), and an intravenous catheter will be placed in the non-dominant arm. Participants will receive a standardized snack, and dinner \~4 hours before the start of the trial. Participants will be instrumented for microneurography. Participants will be awake in bed in dim light (\<8 lux). An investigator will constantly be present in the control room to monitor and ensure constant supine posture and wakefulness. Polysomnography, beat-by-beat BP, and neurogram for microneurography will be done throughout each trial into awakening; blood will be sampled before, during, and immediately after each trial (total of 8 samples in each trial). Flow-mediated dilation will be conducted before bed and after bed. The two trials will be conducted \~one month apart to accommodate the menstrual cycle phase in pre-menopausal females.
Overnight Sleep Trial
Participants will wear an ambulatory BP monitor upon admission. Participants will be instrumented with full polysomnography (except leg myogram), and an intravenous catheter will be placed in the non-dominant arm, and then participants will receive a standardized snack, and dinner 4 hours before the start of the trial. Polysomnography, beat-by-beat BP, and neurogram for microneurography will be done throughout each trial into awakening; blood will be sampled before, during, and immediately after each trial (total of 8 samples in each trial). Participants will be instrumented for microneurography. Participants will begin an 8-hour sleep opportunity (\<0.1 lux) at their chosen sleep time. At the end of the sleep episode, participants will be gently awoken in a standardized fashion by use of a mild auditory stimulus. Flow-mediated dilation will be conducted before bed and after sleep. The two trials will be conducted one month apart to accommodate the menstrual cycle.
Regularized Sleep Schedule
All participants will be asked to maintain a self-selected bedtime (sleep duration not controlled) for two weeks as an intervention after the completion of the constant routine and both the resting wakefulness and overnight sleep trials. During this time, participants will be asked to call a time-stamped voicemail box upon waking and going to bed, as well as complete a daily sleep diary and wear an Actigraph device on their wrist. Ambulatory blood pressure will be measured at home before and at the end of the two-week intervention.
Interventions
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At-home Polysomnography
Participants will complete one night of unattended polysomnography in their home environment (SOMNOtouch RESP, SOMNOmedics America Inc., FL, USA).
Circadian Protocol
Participants will spend 4 days/3 nights in the laboratory to uncover circadian rhythms. After 2 nights for acclimatization and baseline measurements, participants will stay awake for 28 hours in dim light, constant temperature, and semi-recumbent posture. Participants will be provided with standardized snacks regularly. Polysomnography, core body temperature, sleep, finger oximetry, electrocardiogram (ECG), and beat-to-beat BP will (except microneurography) be measured throughout. Blood will be drawn every 2-4h to analyze catecholamines, renin activity, and aldosterone. All other measurements, including BP, heart rate (HR), and flow-mediated dilation will be performed regularly. Salivary samples will be collected every 2hrs (when awake) to analyze melatonin levels. A recovery sleep period will be provided and baseline testing procedures will be performed. Investigators may acquire direct recordings of sympathetic activity using microneurography.
Rested Wakefulness Trial
Participants will start wearing an ambulatory BP monitor upon admission. Participants will be instrumented with full polysomnography (except leg myogram), and an intravenous catheter will be placed in the non-dominant arm. Participants will receive a standardized snack, and dinner \~4 hours before the start of the trial. Participants will be instrumented for microneurography. Participants will be awake in bed in dim light (\<8 lux). An investigator will constantly be present in the control room to monitor and ensure constant supine posture and wakefulness. Polysomnography, beat-by-beat BP, and neurogram for microneurography will be done throughout each trial into awakening; blood will be sampled before, during, and immediately after each trial (total of 8 samples in each trial). Flow-mediated dilation will be conducted before bed and after bed. The two trials will be conducted \~one month apart to accommodate the menstrual cycle phase in pre-menopausal females.
Overnight Sleep Trial
Participants will wear an ambulatory BP monitor upon admission. Participants will be instrumented with full polysomnography (except leg myogram), and an intravenous catheter will be placed in the non-dominant arm, and then participants will receive a standardized snack, and dinner 4 hours before the start of the trial. Polysomnography, beat-by-beat BP, and neurogram for microneurography will be done throughout each trial into awakening; blood will be sampled before, during, and immediately after each trial (total of 8 samples in each trial). Participants will be instrumented for microneurography. Participants will begin an 8-hour sleep opportunity (\<0.1 lux) at their chosen sleep time. At the end of the sleep episode, participants will be gently awoken in a standardized fashion by use of a mild auditory stimulus. Flow-mediated dilation will be conducted before bed and after sleep. The two trials will be conducted one month apart to accommodate the menstrual cycle.
Regularized Sleep Schedule
All participants will be asked to maintain a self-selected bedtime (sleep duration not controlled) for two weeks as an intervention after the completion of the constant routine and both the resting wakefulness and overnight sleep trials. During this time, participants will be asked to call a time-stamped voicemail box upon waking and going to bed, as well as complete a daily sleep diary and wear an Actigraph device on their wrist. Ambulatory blood pressure will be measured at home before and at the end of the two-week intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18.5-42kg/m2
* Hypertension (average resting blood pressure between 130/80 mmHg and 160/100 mmHg)
Exclusion Criteria
* Prior shift work within 12 months prior to the study;
* Travel greater than three time zones for at least 3 months;
* History of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction;
* Acute or chronic diseases (except hypertension) that may affect outcome measures;
* History of psychological conditions;
* Sleep disorders, like severe sleep apnea, insomnia, etc.;
* Prescription medications (Contraceptives and anti-hypertensive medications are permissible);
* History of Illicit drug use and alcohol dependency;
* 30 days free of cannabis use prior to the study;
* Pregnancy;
* Upper cut-off of 160/100 mmHg for BP
25 Years
64 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Saurabh Thosar
Assistant Professor
Principal Investigators
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Saurabh S Thosar, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00023776
Identifier Type: -
Identifier Source: org_study_id
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