RecruitingNot ApplicableNCT05184933

Sleep and Circadian Mechanisms in Hypertension


Sponsor

Oregon Health and Science University

Enrollment

32 participants

Start Date

Aug 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a mechanistic clinical trial designed to investigate the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN).


Eligibility

Min Age: 25 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how sleep patterns and the body's internal clock (circadian rhythm) affect high blood pressure. Researchers want to understand whether disrupted sleep contributes to elevated blood pressure. **You may be eligible if...** - You are between 25 and 64 years old - You have high blood pressure (readings between 130/80 and 160/100 mmHg) - Your BMI is between 18.5 and 42 kg/m² **You may NOT be eligible if...** - You have a history of heart failure, heart attack, bypass surgery, or stroke - You have a sleep disorder such as severe sleep apnea or insomnia - You have smoked heavily (more than 5 pack-years) - You have done shift work in the past 12 months - You are pregnant - You have a history of drug or alcohol dependency - You use cannabis and have not been cannabis-free for 30 days - Your blood pressure is above 160/100 mmHg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAt-home Polysomnography

Participants will complete one night of unattended polysomnography in their home environment (SOMNOtouch RESP, SOMNOmedics America Inc., FL, USA).

OTHERCircadian 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.

OTHERRested 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.

OTHEROvernight 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.

BEHAVIORALRegularized 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.


Locations(1)

Oregon Health and Science University

Portland, Oregon, United States

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NCT05184933


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