Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT05184933

Conditions

Hypertension

Cardiovascular Diseases

Cardiovascular Risk Factors

Circadian Rhythms

Sleep

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not accepted

Interventions

At-home Polysomnography

Circadian Protocol

Rested Wakefulness Trial

Overnight Sleep Trial

Regularized Sleep Schedule

Study Details

Brief 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).

Conditions

Hypertension

Cardiovascular Diseases

Cardiovascular Risk Factors

Circadian Rhythms

Sleep

Study ID

NCT05184933

Start date

Aug 4, 2022

Status verified date

Mar, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 25-64
  • BMI 18.5-42kg/m2
  • Hypertension (average resting blood pressure between 130/80 mmHg and 160/100 mmHg)

Exclusion Criteria:

  • Over 5 pack-years of smoking;
  • 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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

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.

Primary outcome measure

  • Sleep duration (At-home Polysomnography) [ Time Frame: 1-2 nights ]
  • Sleep Episodes (At-home Polysomnography) [ Time Frame: 1-2 nights ]
  • Blood pressure (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Heart rate (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Heart rate variability (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Epinephrine (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Norepinephrine (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Aldosterone (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Renin (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Vascular endothelial function (Circadian and Overnight sleep vs. rested wakefulness trial) [ Time Frame: 7 days ]
  • Magnitude of overnight blood pressure dipping (Overnight sleep vs. rested wakefulness trial) [ Time Frame: 2 days ]
  • Muscle sympathetic nerve activity (MSNA) (Overnight sleep vs. rested wakefulness trial and circadian trial) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Nicole Chaudhary, MPH

5034945536clinphys@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Saurabh S Thosar, PhD

503-494-2064clinphys@ohsu.edu

Principal Investigator:

Saurabh S Thosar, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 11, 2026

Last verified

Mar, 2025

Keywords

  • cardiovascular
  • circadian rhythms
  • sleep
  • blood pressure
  • constant routine
  • microneurography
  • hypertension
  • sleep regularization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-02-11.