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Nighttime blood pressure mystery: researchers track hidden heart risk
NCT ID NCT03598894
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at people with high blood pressure whose levels don't drop normally during sleep, a condition linked to worse health outcomes. Researchers will use wearable devices and smartphone apps to monitor blood pressure patterns over 24 hours. The goal is to understand how stable this 'non-dipping' pattern is and what biological rhythms might be involved.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors better understand and identify a risky form of high blood pressure that doesn't drop at night, potentially leading to more personalized treatment.
- What could go wrong
- This is an observational study, not a treatment trial. It aims to gather data, not test a cure or therapy, so direct patient benefits are not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Cohort 1 (case): Individuals with (Phase 1-) confirmed non-dipping phenotype 'NDHT'; Cohort 2 (control): matched healthy normotensives 'NT' (24h mean wake SBP \<120mmHg); Cohort 3 (control): matched dipping hypertensives 'DHT' (24h mean wake SBP \>145mmHg and a decline of \>10% between mean day time and night time systolic pressures);
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Phase 1: Inclusion Criteria (Stability of the non-dipping phenotype) 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. 24h mean wake SBP \>145mmHg at baseline from 24hr-ABPM readings within the past 12 months, 4. Decline of \<10% between mean day time and night time systolic pressures quantified per 24hr-ABPM within the past 6 months, 5. Own a smartphone. Phase 1: Exclusion Criteria (Stability of the non-dipping phenotype) 1. Known history of severe psychiatric or cognitive conditions, for example mania, schizophrenia, or mental retardation. 2. Shift work, defined as recurring work between 22:00-05:00, 3. History of clinically significant obstructive sleep apnea; 4. Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women, 5. Significant liver disease (\>3x upper limit of normal), 6. Diabetes mellitus, 7. Transmeridian travel across ≥2 time zones in the month prior to ABP sessions, 8. Planned transmeridian travel across more than ≥2 time zones during the planned study activities; 9. \> 2 drinks of alcohol per day; 10. Use of illicit drugs which affect blood pressure; 11. Use of pacemaker or implantable Cardioverter Defibrillator, (ICD); 12. Bilateral mastectomy; 13. Hypotension, defined as 90/60 mmHg assessed during the screening visit from ≥ 3 in-office measurements initiated after 10 minutes in seated upright position with 5 minute intervals between measurements; 14. History of Raynaud's phenomenon; 15. Known allergy against natural latex rubber (contained in ABP bladder and tubing); 16. Nursing or pregnant females. Phase 2: Inclusion Criteria (Deeply phenotyping non-dipping hypertensives) Inclusion Cohort 1 (case): non-dipping hypertensives 'NDHT' 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. 24h mean wake SBP \>145mmHg from 24hr-ABPM readings confirmed per data base query within the past 12 months prior to enrollment into Phase 1 and across two subsequent 24hr-ABP sessions during Phase 1, 4. Decline of \<10% between mean day time and night time systolic pressures from 24hr-ABPM readings confirmed per data base query within the past 12 months prior to enrollment into Phase 1 and across two subsequent 24hr-ABP sessions during Phase 1, 5. Own a smartphone. Inclusion Cohort 2 (control): matched healthy normotensives 'NT' 1. \>18 years of age, 2. Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 3. Healthy (as assessed by health history, physical exam and screening lab work), 4. 24h mean wake SBP \<130mmHg quantified per 24hr-ABPM, 5. Own a smartphone. 4.3.3 Inclusion Cohort 3 (control): matched dipping hypertensives 'DHT' 1\) \>18 years of age, 2) Upper arm with intact skin, i.e. without areas of breached or injured skin visible, for ABP measurements, 1. 24h mean wake SBP \>145mmHg from 24hr-ABPM readings, 2. Decline of \>10% between mean day time and night time systolic pressures from 24hr-ABPM readings, 3. Own a smartphone. Phase 2 - Exclusion Criteria Cohorts 1-3 1. History of severe psychiatric illness or cognitive conditions, for example ( mania, schizophrenia, or mental retardation; 2. Shift work, defined as recurring work between 22:00-05:00; 3. Clinically significant obstructive sleep apnea as assessed per WatchPAT device; 4. Urine creatinine \> 1.5 mg/dl in men or \>1.3 mg/del in women; 5. Significant liver disease (\>3x upper limit of normal); 6. Diabetes mellitus; 7. Past diagnosis of gastroesophageal reflux disease, 8. Transmeridian travel across ≥2 time zones in the two weeks before the 48hr deep phenotype sessions; 9. Frequent transmeridian flyer (≥2 flights per month) across more than ≥2 time zones during the 12 months of study activities; 10. Use of oral or intravenous antibiotics in the 6 months prior to enrollment; 11. Any contraindication listed below in the separate paragraph "Contraindications for the use of CorTemp® Disposable Temperature Sensors"; 12. Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; 13. \> 2 drinks of alcohol per day; 14. Use of illicit drugs which affect blood pressure; 15. Nursing or pregnant (pregnancy will be repeatedly assessed at the beginning of each of the four inpatient visits, i.e. prior to the start of blood draws); 16. Use of pacemaker or implantable Cardioverter Defibrillator, (ICD) 17. Bilateral mastectomy; 18. Hypotension, defined as 90/60 mmHg assessed during the screening visit from ≥ 3 in-office measurements initiated after 10 minutes in seated upright position with 5 minute intervals between measurements; 19. History of Raynaud's phenomenon; 20. Known allergy against natural latex rubber (contained in ABP bladder and tubing); 21. Subjects taking medication with alpha-blockers; 22. History of clinically significant arrhythmias; 23. Subjects with a history of being particularly susceptible to vomiting or nausea; 24. BMI ≥ 30; 25. History of any type of GI Surgery.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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